It's 3:30 PM here where I am and I am watching a live session (on TV) from the White House. Dr. Anthony Fauci, Director of NIAID just spoke and said this:
"We are looking only at treatments that will be conducting randomized controlled trials for the treatment of COVID-19 treatments/cures/vaccines".
He also said that the Federal government would not hesitate to drop hundreds of millions of dollars to support any company(s) in helping them in this regard.
Here is my analysis:
In this Benzinga article (see link below) which has been posted by others on HC previously, Dr. Silviu Itescu talks about "..plans to launch arandom controlled trialin 48 patients “in the next few weeks...”
https://www.benzinga.com/general/biotech/20/03/15606408/this-company-made-back-pain-therapies-now-its-out-for-a-covid-19-drug
So folks, have patience. What SI said perfectly aligns with what Dr. Fauci of the NIAID is saying. It is clearly telling me that SI had discussions with the FDA a while back and was given guidance on what was acceptable.
I do understand people's frustrations (including mine) that SI should have notified the 'market' in a formal PR about the planned trial instead of speaking to a Benzinga reporter. Instead, we have been guessing and second guessing each other about what is going on behind closed doors.
Also, a clarity is needed from SI about MSC patents (especially since the last PR from Mesoblast mentioned the 7 patient Chinese MSC treatment for ARDS along with a footnote about Mesoblast owning over 1000 patents). Question being.... if Mesoblast owns the patents, then why are other companies supplying MSCs to the Chinese? What are MSB's patents on?
And NO. The MSCs supplied to the Chinese 7 patient study were NOT by Mesoblast. Let's settle that discussion right now.
Lastly, the Chinese trial (by Leng Z., et.al) was not a randomized controlled trial - and in my opinion, is not acceptable by the FDA.
I firmly believe that Mesoblast will come out on top (with its capability to scale mass production by Lonza) to get a treatment for COVAID-19 induced ARDS.
Stay safe!!
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