Saturday, May 16, 2020

Personal Blog # 16 … COVID-19 Decisions for Caregivers With Loved Ones in Assisted Living Facilities and Nursing Homes … 5/16/20

As stressful as this “new normal” has been for me as a former Alzheimer’s disease (AD) spouse caregiver who recently moved on with his life, I can only imagine how much more stressful it is for those who are caregivers now … especially for those whose loved ones are in in long-term care facilities.  Most Assisted Living Facilities (ALFs) and Nursing Homes (NHs) now prohibit visitors due to this pandemic.  That restriction alone would have caused me enormous additional stress, anger, and sadness. 

Should caregivers leave their loved ones in ALFs or NHs, or bring them home?  My wife’s worsening medical conditions eventually necessitated a transfer from her ALF to a NH, and many caregivers are probably considering a similar transfer for their loved ones this year.  I cannot say for sure what I would have done had COVID-19 been around when I made my decision, but sharing factors that would have influenced my decisions may be helpful for caregivers facing these questions today.

Should you leave your loved ones in ALFs … or should you bring them home?  It was a difficult decision to place my wife in an ALF.  When we retired, we both made the decision that if either of us would be unable to care properly for the other, we would place that person in an ALF or NH instead of hiring home health aides.  We then took out long-term health care insurance policies to help us do that in such an eventuality.  So, unlike most caregivers considering ALF or NH placements for their loved ones, money was not a factor for me.  As my wife’s AD worsened to where I felt she would receive better care in an ALF, I made the decision to place her and did not look back. 

My wife entered her ALF in 2013.  If COVID-19 had been around and I was prohibited from visiting, and if there were rising death rates in my wife’s facility, I think I would have brought her home. Although neither of us wanted this, and even though my long-term health care policy would not have covered those costs, I think I would have brought her home and hired personal live-in help.  Why? 

As stressful as it would have been to have home health aides living in my house for so many hours each day, the aides would have enabled me to still have some respite time for myself while also having responsibility for supervising my wife’s Activities of Daily Living (ADLs).  I would have let the aide supervise her daily hygiene, dressing, eating, medications, etc. … but I would have been able to hold her tightly, kiss her, talk to her, and tell her I loved her just as I did when visiting her in the ALF. 

I think I would have wanted to maintain that emotional and physical connection with my wife for as long as possible.  I am not saying that would be the best decision for all caregivers, but I think that would have been the best decision for me.  My wife was no longer actively participating in or enjoying activities at her ALF, and I cannot imagine her suffering more as a result of a decision to take her home.  Taking her home would have added to my stress, for sure, but I think that I would have been even more stressed if I had been unable to visit her and worried about her dying of COVID-19. 

So, were my wife in an ALF now, I am pretty sure that I would have brought her home.
However, whereas that decision would have been best for me and my loved one, other caregivers must make their own decisions as to what is best for themselves and their loved ones.  Resources to pay for either ALF placements or home health aides are certainly important factors to consider, as well as the age and medical condition of your loved one. The caregiver’s quality of life issues must also be considered. 

The most important influential factor may be the relationship you currently have, and once had, with your loved one.  My loved one was my wife of nearly 50 years whom I loved beyond words.  Would I have made the same decisions were that loved one my brother or sister, father or mother, in-law, or close friend who had given me power of attorney to make those decisions?  I cannot answer that question.  I just don’t know. I do know that it was extremely important for me to maintain my emotional and physical bonds with my wife for as long as possible.

What if I knew that visiting restrictions would soon be lifted because the worst of this virus had passed?  Would I have then decided to leave my wife in her ALF, hoping that she would remain well while knowing that I could start visiting again and in just a few more days or weeks?  Even given that scenario, I think that I still would have brought her home. 

Is it best to transfer loved ones from an ALF to a NH now … or should you bring them home?  When my wife was no longer able to participate in ALF activities, when I was paying for more and more hours for personal 1:1 aides, and when she was experiencing more medical issues, I decided to transfer Clare from her ALF to a NH.  An interim period of hospitalization facilitated the transfer and she was discharged from the hospital directly into a NH.  But given the data we now see about deaths in NHs around the country, and especially in NY, I would not have transferred my wife to a NH … nor would I have had her transferred back to her ALF.  I would have brought her home.

Given my strong need to see her, hug her, and kiss her … and talk to her even though I could no longer talk with her … I would have brought my wife home when discharged from the hospital.  I would have paid for home visits by nurses and therapists, taken her to doctors when necessary, and paid for  personal aides at home rather than be unable to visit her in a NH … and worry about her dying due to COVID-19.  But, as noted earlier, this is a decision I made for a loved one who was my wife.  Were my loved one someone other than my wife, I cannot say what decision I would have made because, if for no other reason, my emotional and physical bonds with my wife were infinitely stronger than with anyone else in my life.

So … what is my advice to caregivers facing these extremely difficult, stressful and painful decisions, made even more difficult, stressful, and painful due to this pandemic?  I can only speak for myself, and at this time I personally would not want my wife to be in an ALF or NH with a high death rate, with or without visitor restrictions.  That may not be the “right” decision for you … but that would have probably been the right decision for me.
ALF and NH placements are already difficult decisions, now made even more difficult during this pandemic.  All caregivers must come to these highly personal decisions by themselves, and what is “right” for one caregiver may be “wrong” for another caregiver.  Unless someone else is in your shoes … and no one else is … no matter how critical others may be if your decision is not to their liking, no one else can fully appreciate whatever factors weigh most heavily in any decision you reach.
Knowing that there is no one “right” decision for all caregivers, my advice is simply this:  Do what you think is best for you and your loved one.  Whatever you decide to do … or not do … is the “right” decision.

Thursday, April 9, 2020

Personal Blog #15 ... Avoiding Sadness and Depression While Coping With COVID-19 ... 4/19/20

Like everyone else in this country … not just those currently dealing with Alzheimer’s disease (AD) as a caregiver, or those now trying to move on as AD widows or widowers … I am struggling to deal with COVID-19 guidance to remain at home.  Here on Long Island, NY … a current “hot spot” for this disease …I have already self-isolated at home for 3+ weeks, but I’m afraid that, at least in NY, self-isolation may continue well into May.

We have many heroes here on Long Island… doctors, nurses, and everyone else in the health care profession … first responders continuing to do their jobs each day … all the people performing essential services to transport food and stock grocery store shelves, deliver online packages, make hospital masks … and the many, many people helping others in need through their essential work or charitable contributions and activities.  All of these “ordinary people” are genuine heroes.

I am not one of those heroes.  I am simply a 73 year old Alzheimer’s widower trying to do my part to help my fellow Americans, staying home so I don’t unintentionally contract this coronavirus and get sick myself …or worse, become infected and spread COVID-19 to others.  Doing either would unnecessarily add further stress to our health care services and facilities, and possibly lead to otherwise avoidable sickness and death.

However, as someone who has only recently started to find light at the end of a very long tunnel, I am now struggling with a bad case of “cabin fever.” On some mornings, I don’t even want to get out of bed.  I’m already sick of reading, watching TV, listening to music, walking, playing word games, etc.  I fully support social distancing and government “stay-at-home” advisories and wish everyone would feel the same, but it’s definitely getting increasingly difficult for me to remain positive.

I’m emailing and texting, and “seeing” my friends and family through  Skype and What’s App.  But it’s just not the same as being with them … hugging them, kissing them.  I miss that physical contact so very much.  I miss my bowling leagues and my gym workouts, and all the other aspects of my pre-coronavirus life.

To help deal with my cabin fever, I have returned to re-reading portions of my April, 2017 article, “Inspirational Thoughts for Alzheimer’s Caregivers, Widows, and Widowers.”  I wrote about thoughts and songs that got me through my most difficult moments as an AD spouse caregiver, and then as an AD widower.  Quoting excerpts from my 2017 article …

In “By the Grace of God,” (Katy) Perry sings about how, after a love break-up, she finds herself lying on her bathroom floor.  She sings, “I picked myself back up, I knew I had to stay, I put one foot in front of the other, I looked in the mirror and decided to stay.”  There were many other phrases in “By the Grace of God” that I related to ... lines such as “running on empty, so out of gas” and “found I wasn’t so tough.”  But that song also had the line, “I am not giving up.”  Something else that helped me a lot was re-reading the “Serenity Prayer.” 

Unfortunately, due to my cabin fever I am again experiencing days when I’m “running on empty, so out of gas” … days when I find that I am not “so tough.”  To get through these difficult times, I am trying to simply place “one foot in front of the other” because, as Perry also sang, “I am not giving up.”

I have come so far in these past 4 years.  I will not give up now.  I need to try harder to find “the serenity to accept the things I cannot change and change the things I can.”  I must try harder to find courage in the words of the “Serenity Prayer” and discover better ways to spend my time at home.  I need to get involved in new activities that will bring me happiness so I can avoid sliding back into a period of overwhelming sadness or depression

All of us dealing with loss and pain … and all of us who have moved on to find happiness … must continue doing whatever it takes to remain positive.   Despite coronavirus, we can pick ourselves back up from feelings of despair and move forward … just by putting one foot in front of the other.  

We cannot give up.  Stay safe.  Stay strong. 

Sunday, March 22, 2020

Personal Blog #14 ... Continued Happiness ... 3/22/20

I have already posted several Personal Blog columns about my difficulties trying to move on with the rest of my life after losing my wife of nearly 50 years to AD.  This is the last time, however, that I will post a Personal Blog column about this topic.  However, I am planning to continue posting occasional columns on other issues related to AD and caregiving. 

There will be no more columns about my personal struggles to find new happiness because that long battle has been fought … and finally won … even if current or future realities, such as dealing with the effects of the coronavirus, may cause an occasional step backwards now and then.

After 10 years of an almost daily “new normal” while Clare struggled with AD and after grieving for years while Clare was still alive … only to be followed by 2+ years of serious depression and then another 18 months of overwhelming sadness after her death … I have finally arrived at another new normal, one that has brought great happiness back into my life.

Despite our entire world being turned upside down by the coronavirus pandemic … talk about a worldwide new normal … I am now very optimistic about my future.  Why?  Because shortly before the virus began making daily headlines, I had already “found” new happiness.  By sheer serendipity, a woman I had known for many years, also a caregiver, re-entered my life.  We started meeting occasionally at diners simply as friends enjoying breakfast, but our relationship quickly and unexpectedly morphed from friendship to deep affection to emotional and physical love.
The physical portion of our new relationship is now, sadly, “on hold” due to the virus constraints and sensible precautions that we must take.  However, we continue to express our happiness through daily texts and phone calls, along with an occasional walk at the beach while practicing social distancing.  Despite current virus restrictions keeping us apart, we both now know that we can look forward to a wonderful future together. 

That is a future I had almost given up on ever finding again.  In Personal Blog #10 (“Life After Moving On), posted on 9/2/19, I wrote about how I had finally moved on in many aspects of my life as a widower, even summoning the courage to try meeting new women through online dating sites.  But I had not yet found that “special woman” I was looking for … that special woman who would bring to my life “more happiness, less sadness, and less loneliness.”  I was still hoping to find my “second act.”

And now, quite unexpectedly, I have found that second act.  For the first time in many, many years I am smiling, laughing, and thoroughly enjoying my time with a special woman again.  For the first time in many, many years I am truly enjoying being alive again.  For the first time in many, many years I now see my future filled with happiness.

Readers may recall that I have written about how Clare had left a letter for me on her computer, a letter she had written when she recognized that she was losing her cognitive functioning.  However, she never told me about that letter.  It was only when going through her computer files after she died that I discovered that letter, as well as a letter for each of our children.  Clare’s letter to me was extraordinarily beautiful, expressing her hope that I would “find continued happiness” after she was gone.  It has taken me nearly 4 years, but I have now finally found that continued happiness.

I hope that readers who have also had problems “moving on” have found some comfort in my Personal Blog columns on this topic … mostly by discovering that they are or were not alone, but also by reading about how my path to finding happiness has been very bumpy with many setbacks along the way.  And yet … I am now enjoying that happier life I sought.

Some widows and widowers seem able to put their grief behind them in a matter of weeks or months and then move on with the rest of their lives.  I certainly was unable to do that.  However, I am now a witness to the reality that even after an extended period of grief, depression, and sadness it remains possible for a widow or widower to find that special someone … it remains possible to find that special someone and enjoy a wonderful “second act” of a life filled with happiness.

If steps you have taken to find more happiness, less sadness, and less loneliness as a widow or widower have not yet been successful, please don’t give up on yourself.  Please consider taking more new steps to try to find that happier future, while also remaining open to possibilities that may arise from chance encounters.  I never thought of my friend as that “special someone” for me … and yet, happily, it turned out that she was.
All widows and widowers deserve to find happiness again … we all deserve to find that second act.  Please do not let the death of your loved one end your quest to find continued happiness.  

Friday, January 17, 2020

Surviving a Partner's Alzheimer's Disease -- Losing Twice

I lost my wife, Clare, to Alzheimer’s disease (AD) in the spring of 2016 and with 2020 now here I am still struggling to fully move on with the rest of my life. I did not expect to have such a long struggle because I had already felt widowed for several years before Clare died. She was confused all the time, she was increasingly unable to express herself in words, she no longer knew who I was, and we had been living apart. Her mental faculties were gone, and “Clare wasn’t Clare” anymore. I was grieving that loss every day.
But even after Clare’s mind was gone, I could still be with her. I held her hands, hugged her tightly, kissed her, and told her how much I loved her. Usually there was no response, sometimes I received a smile, and on those increasingly rare days when she would say a few words in response, her words were often, “Can you please find my husband?” Clare was “there” with me, yet really “not there” with me at all.
With no cure for AD, once your spouse or partner receives an AD diagnosis, it can become a death sentence. The unanswered question is how much quality time you may still have together. I started observing AD symptoms when Clare was 60 and her AD diagnosis was confirmed a few years later. After her diagnosis, we were only able to enjoy a few more good years together.
A fellow AD spouse, who was also still experiencing similar sadness and loss after the death of her husband, noted that losing someone you love to AD really means having to deal with death twice—first when you lose their mind, and then again when you lose their body.
That is a profound way to look at loss due to AD, especially for a surviving spouse who had been in a long and loving marriage. Once unable to have even the most basic conversations with an AD partner, the survivor begins grieving an almost unbearable loss. No longer being able to share the highs and lows of daily life, and no longer being able to share the joys of common memories is a difficult loss to face. In a very real way, once unable to communicate with your AD partner, the survivor may begin to mourn just as though their AD partner had already died.
However, surviving spouses and partners can still be with their loved one after their minds are gone. Even with no reactions or responses, survivors can continue to hold their hands, hug them, kiss them, and tell their AD partners they love them. Even when no longer able to talk with them, survivors can still talk to them.
Being able to hold a beloved AD partner in your arms while you talk to them, even when there is no verbal or physical reaction of any kind, can provide at least a small degree of emotional comfort for the survivor. Physical contact can, even if only for fleeting moments, help resurrect cherished memories that may counter some of those enormous feelings of daily sadness that never seem to leave.
A few months or years later, when a person loses their partner’s body, the survivor begins grieving painful loss a second time. Moving on after the loss of an AD partner’s physical presence, while still mourning the earlier loss of their mind, is a lot to move on from.
Social workers who facilitate support groups for those who have lost a partner to AD must understand that survivors may experience death differently than those in other support groups.
With Alzheimer’s, loved ones may experience a double loss.
— Allan S. Vann, EdD, a widowed spouse/caregiver, has written many articles to help AD caregivers, including several that have been published in Social Work Today. Caregivers can read copies of all of his published articles on Vann’s website at

Published in Social Work Today, online only .  Access at:

Wednesday, January 8, 2020

Personal Blog #13 ... Dementia Patients in Hospital Emergency Departments

I have written several articles describing how poorly my late wife, a victim of early onset Alzheimer’s disease (AD), was treated whenever she was in a hospital Emergency Department (ED).  My ED experiences as her AD spouse caregiver were uniformly poor.  I always found nurses to be extremely competent and empathetic.  However, I almost always found doctors to be ignorant about how to communicate with her effectively, let alone how to diagnose and treat her effectively.  In addition, many times her doctors, and technicians, routinely refused my offers to provide information that would help them diagnose and treat her more effectively.  As a result, my wife suffered needlessly during each visit.

In my March/April 2018 article in Annals of Long-Term Care, I wrote a response to an article published in that journal’s previous issue about the American Geriatrics Society’s formation of the Geriatrics Emergency Department Collaborative (GEDC), a consortium of some of our country’s leading health systems and medical societies, “to help improve emergency care for our nation’s older adults.”  I expressed my appreciation for this initiative, but I also noted that there was no mention of the GEDC seeking input from the caregivers of dementia patients … the very people who could offer firsthand observations of patient care, and who could suggest possible recommendations for improved practice based upon their experiences.
The GEDC’s stated goal is to improve “healthcare outcomes” for older people in EDs. 

Their website ( states, “We are committed to making change through the education of individuals, and hospital-wide initiatives that create sustainable improvements in practice at all levels.”  The GEDC has now applied for a five year grant through the NIH (National Institutes of Health) and NIA (National Institute of Aging) “to support the development of a collaborative research and resource network to synergize the expertise, skills, and resources of investigators within the geriatric emergency medicine and Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) research communities, to identify and address research gaps towards optimizing recognition and emergency care of older adults with AD/ADRD.”

Last month I was honored to be asked to serve on the Geriatric Emergency care Applied Research (GEAR 2.0) Task Force that will implement this grant if it is funded.  In my role as a former AD spouse caregiver, I will be able to provide a voice for dementia caregivers and their loved ones, and to describe what it’s like for dementia patients and their caregivers in an ED.  I will also serve as a dementia patient advocate to provide a voice for recommending improved medical training for ED personnel, and improved ED practices and procedures.

Should you have suggestions for improving patient care in hospital EDs, please email them to me at and I will try to include them in my recommendations to the Task Force.  Meanwhile, I will provide periodic updates of the status of this grant proposal on this website.  It’s been almost four years since I was in an ED with my wife, and I would like to think that doctors have made some progress in learning how to communicate effectively with patients experiencing moderate or severe stages of AD or some other form of dementia.  I would also like to think that doctors have made some progress in learning how to effectively examine and diagnose dementia patients brought to their ED.  Sadly, dementia caregivers tell me this is still not happening. 

Please let me know if you have suggestions for ED improvement based upon your own personal experiences as a dementia caregiver.  This grant may be a genuine opportunity for caregivers to make a difference … to really affect the training of current and future ED doctors and improve the procedures followed in EDs across the country.  Let’s make the most of it!

Tuesday, December 10, 2019

Personal Blog #12 … More Data on Aducanumab … 12/10/19

According to an article published by The Associated Press on December 5, 2019 Biogen’s scientists issued a preliminary report on their new data analysis of their Alzheimer’s disease (AD) medication, aducanumab.  This is the medication that was in a Phase III clinical trial that was ended in March due to poor results but, after new data came in after the trial ended, was then promoted by Biogen as being effective.

Biogen’s presentation received very mixed reactions from scientists at an Alzheimer’s conference in San Diego, California on 12/5/19.  According to the A.P. article, scientists were “sharply divided over whether there’s enough evidence of effectiveness for the medicine to warrant federal approval.”  The new data released that day indicated that “the drug made only a very small difference in thinking skills in one study and none in the other.”  A.P. reports that independent experts said that “the new analyses were done on partial results, and with methods not agreed upon at the outset, making any conclusion unreliable.”

Some scientists cheered the new results and some judged them insignificant.  “Questions arose about the size of any benefit.  The drug did not reverse decline and it only slowed the rate of it compared to the placebo group by 22% in one study.  Yet that meant a difference in only 0.39 on an 18-point score of thinking skills.”

As I’ve written many times before, the currently FDA-approved AD medications have been shown to be effective for only about 50% of the people who take them, and then only for up to a year or two at most.  But, sadly, once doctors place their AD patients on these expensive medications, doctors are reluctant to ever remove their patients from these meds …  even though there is absolutely zero research to indicate that these meds have been or still may still be effective.  The result is that too many caregivers and AD patients continue to pay a lot of money year after year for AD meds that I refer to as “expensive bottles of hope” when that money could be much better used for day care, respite opportunities, or to help pay for home or institutional care.

I sincerely hope that, if this is the best new data Biogen can present to the FDA in support of their application to market aducanumab, the FDA resoundingly says no to marketing at this point.  If Biogen scientists think their data suggests promise, then let them conduct new year-long Phase III clinical trials with proper supervision.  That is the only way to demonstrate effectiveness.  Scoring one point more on a test of thinking skills is no reason to add yet another expensive bottle of hope to the market.

Saturday, November 2, 2019

Personal Blog #11 ... Is Aducanumab an Effective Treatment for Early Stage Alzheimer's? ... 11/2/19

Of the top 10 causes of death in this country, Alzheimer’s disease (AD) is the only one with no effective means of prevention, treatment or cure. Any pharmaceutical or biotech company that discovers medication to effectively treat, let alone prevent or cure AD, will help millions of people … and make millions of dollars.  We often see reports of successful Phase I or Phase II clinical trials demonstrating positive effects of new experimental AD medications, but we have yet to see reports of effectiveness in a Phase III clinical trial.  The National Institutes of Health (NIH) describes the different phases of clinical trials as follows:  (Note: the NIH website may be accessed at …

"Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
  • Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
  • Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
  • Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.)"

Biogen, a major biotech company, ended its Phase III clinical trial with a new experimental medication, aducanumab, on March 21, 2019 because testing results indicated that it was ineffective.  So how is one to interpret Biogen’s announcement on October 22, 2019, that it will ask the FDA to approve aducanumab as a new treatment for early stages of AD? 

On their website,, Biogen states that after their study ended in March, “a new analysis of a larger dataset” showed that … “Patients who received aducanumab experienced significant benefits (my underlining) on measures of cognition and function such as memory, orientation, and language.  Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.”  Biogen plans to submit their new data to the FDA in early 2020 to seek approval to market aducanumab.  

If the FDA determines that Biogen’s data support aducanumab as an effective treatment to slow the effects of AD, that would be a major step forward and offer tremendous hope to people with AD and their caregivers.  But before I get too excited, I want to see that results reported as “significant benefits” are what I refer to as “real world” benefits.  Reports of “statistically significant” results on paper/pencil tests measuring cognition, or of brain scans or biomarkers measuring a decrease in amyloid beta protein in the brain, are always welcome. 
However, such measures do not necessarily translate into more effective patient functioning at home or in a facility.  Answering 1 or 2 more questions correctly on a cognitive test or remembering 1 or 2 more words on a memory test may yield “statistically significant” results but may not always mean more effective functioning in the real world.  However, medication resulting in significant improvement for people with AD for 6-12 months or longer as they deal with activities of daily living or who can continue to go shopping or travel independently outside the home … to me, that would be a major game changer.  Such benefits would allow the person with AD to enjoy a much better quality of life for a much longer period of time. 

If Biogen follows through on its current plans, this will the first time that a company has ever ended a “failed” Phase III clinical trial of an experimental AD medication … then re-analyzed additional data … then claimed that this additional data support effectiveness of its medication … and then requested submission to FDA for approval to market.  After reviewing the research findings submitted by Biogen, the FDA can approve the medication, reject the medication, or find some evidence of effectiveness … but not conclusive enough evidence to warrant approval … and require additional clinical trials.

As a former AD spouse caregiver, I hope that the FDA will concur that aducanumab can be that major AD game changer after reviewing data submitted by Biogen.  But, until the FDA makes a decision, I will remain skeptical.  Biogen announced that it plans to report their new data and seek approval from the FDA in “early” 2020.  Stay tuned!