Since I don't read HC everyday (I sometimes go days/weeks from reading HC), I missed reading this thread until this morning. I saw the above post from
@herro (thanks
@herro ) which made me really happy. Then I saw some other posts detailing negative comments at the FDA site, urging the FDA
NOT to approve Remestemcel-L for aGVHD, which made me really irate.
Anyway, just a while ago, I contacted Gerald Cowden, father of Meredith Cowden by phone and had a 15 minute conversation. Meredith Cowden left the comments at the FDA website link below:
https://beta.regulations.gov/document/FDA-2020-N-1539-0027
You have to download her comments at the above link in order to read them. I have attached her comments to this post, just in case - here -->
Cowden Comments.pdf
1. Meredith was away when I called but I talked to her father, Gerald. As you can read from her comments, Meredith is a cancer survivor and has struggled with aGVHD all her life.
2. Gerald and Meredith run the Meredith A. Cowden Foundation and you can read all about it here:
https://cowdenfoundation.org/
3. The Foundation supports research and is committed to "Providing funding for research to prevent, treat and cure Graft vs. Host Disease (GvHD)"
4. The Foundation partners with the Cleveland Clinic, University Hospitals Cleveland Medical Center, Case Western Reserve University, University of Pittsburgh Medical Center, BMT (Blood and Marrow Transplant) Infonet and National Bone Marrow Transplant Link.
5. I informed Gerald about how, as a Mesoblast shareholder, I closely follow Mesoblast's many developments. I told him about how TEMCELL has already been in use in Japan for the past 4+ years. He did say that up until recently, he and his daughter have been singularly focused on the ADULT GVHD arena but they just now made their foray into pediatric aGVHD. Their first effort in this regard was Meredith's comments at the ODAC site.
I told him that Mesoblast would be looking to extend Remestemcel-L use to adults in the future and he was aware of this as he had talked to some folks in the NY office of Mesoblast.
6. I also told him about the upcoming COVID-19 ARDS read out early September (he was not aware of the Remestemcel-L COVID-19 ARDS details)
7. He seemed a bit apprehensive talking to me at first - presumably because of the couple of negative comment makers at the ODAC website and not knowing who/what I represent. Once he knew my stance, he was very warm and thanked me immensely for supporting Mesoblast as he and his daughter strongly believe in the therapy.
8. We also talked about the Lassman Law firm's negative comments posted on the FDA website that urge the FDA to not approve Remestmcel-L. Gerald knows the history of Ryoncil from the Osiris days and the past failed trial. He even knows the reason why it had failed (bad trial design). Quite a knowledgeable fella. He and I agreed that that history has no bearing on the current successful Phase 3 trail, whatsoever.
9.
He also told me that Meredith will be testifying (virtually since the COVID situation) for about 5 minutes at the ODAC on 8/13
Mic drop?
OK so listen up folks:
a) I have submitted my comments on the ODAC website just a while ago. The agency will review it before posting it at the FDA website. My comment tracking number is kdk-pfvr-0z2x. When you submit a comment, you will receive an email acknowledgement. I expect to see my comments posted (appear) on the website soon.
Here is what I posted (my comments) - notice that I posted London Bowater's aGVHD success story in my comments:
Remestemcel-L (or Ryoncil) is a life saving therapy for children afflicted with acute Graft vs Host Disease. This treatment was approved by the Japan PMDA in 2016 and is being used in Japan under the name TEMCELL for the last 4 plus years. It has a long proven safety and efficacy profile. It has also been approved in Canada and New Zealand. It is now high time for us in the United States to approve this so children can start using it. Steroids and other drugs are extremely harmful with debilitating side effects and are just not the answer. Please read this wonderful success story of London Bowater, now 11 years old, who in 2017 has been successfully treated by Ryoncil (Remestemcel-L) at Seattle Children's Hospital:
https://pulse.seattlechildrens.org/promising-drug-combination-silences-gvhd/
I strongly urge the FDA and the ODAC to disregard the misinformation campaign being spread by the Lassman Law and Policy firm, which is working for special interest groups from the Pharmaceutical Industry. We as a nation need to do the right thing. And the right thing is to approve Remestemcel-L which has proved safety and efficacy through a rigorous Phase 3 Clinical Trial. Thank you!
b) I am a bit disappointed I did not know there was a deadline to submit the comments - which was August 6, 2020. But take heart. The August 6 deadline is for comments to be reviewed by the ODAC. Since we are already past that date, comments can still be submitted until midnight August 12 (midnight US time - so roughly noon Australia Melbourne time on August 13) to be considered for review by the FDA.
Here is an excerpt from the FDA website:
"Comments received on or before August 6, 2020, will be provided to the committee. Comments received after that date will be taken into consideration by FDA."
c)
I plead you to submit your comments ASAP at this website. Please do it NOW:
Click on the blue color "Comment" icon at this link:
https://beta.regulations.gov/document/FDA-2020-N-1539-0022/comment
You can wish to be Anonymous or you can provide your first name and Initial of your last name.
Of the 5 comments that have been accepted for posting at that website (mine was just submitted - so it won't show up until it is reviewed and accepted),
3 are NEGATIVE (freaking cannot believe that). Two are in support - one from Meredith Cowden and another from Rakesh Patel from Australia. So yes, there has already been one commenter from Australia.
So let's get on it. Instead of posting on every penny MSB price movement, we owe it to ourselves to do this least bit.
I can tell you this:
Every comment WILL be read. Comments do matter, else why would the FDA request them?
Why would the Lassman Law firm post them? The Lassman Law firm is working for the special interest of Big Pharma. If they think it is worth their while to post negative comments, it is well worth our while to make a favorable case for our beloved Mesoblast.
It's a big deal for us folks. Get on it. Now.
Here's is an excerpt from the snake Lassman Law firm website:
"Scott Lassman has nearly 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice.
He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them"
Says it all.
Some might say "let the science do the talking". True, but what if the approval is delayed due to comments? We just don't want that. Remember, there is a reason the FDA is inviting comments.
PS: Since my last post on 07/29 about US institutions buying MESO (ADR's), there are two more that opened new positions on the NASDAQ:
1. AIIQ - AI Powered International Equity ETF
2. UBS Group AG
And VSGX - Vanguard ESG International Stock ETF ETF Shares
increased their position nearly
4 freaking fold.
(20min delay)