Just a bit of Sunday musing from me...
Firstly IMO most, if not all, of the patients have been recruited by now, it just a matter of waiting for the 30 days to click in.
So, if the first interim doesn’t show overwhelming efficacy, the 2nd or 3rd interim analysis will in a few weeks time.
We are all hoping for overwhelming success on the first interim analysis, and that's still my anticipation that we will get that positive result
; but let’s discuss the risks with this.
What are the risks with the first interim analysis:
1. The SOC has improved and the numbers we have don’t stack up to be overwhelming success
2. Manufacturing scale-up
3. Time lag for full FDA approval
There's no doubt, if we don't get overwhelming success from the first interim analysis then MSB' SP will suffer badly.
As the negativity will be emphasised without any considerations for the details e.g. that Rem-L actually works. Nor the fact that 2nd or 3rd interim analysis will come in a few weeks time.
Hopefully, Ryoncil will be approved for aGVHD prior to the announcement of first interim analysis results, to create a bit of an SP buffer
Granting of EUA - Emergency Use AuthorizationRegardless of the first interim analysis results.
I'm now coming around to thinking that the possibility of Rem-L getting an EUA is realistic.
Both the manufacturing scale-up approval and the actual FDA approval will take time.
SI has mentioned seeking FDA for expedited approval Covid-19 ARDS – what’s more expedited than an EUA?
The FDA defines EUA as
“an expedited authorization and use of an unapproved product or the off-label use of an already approved product in a declared emergency involving a chemical, biological, radiological, or nuclear (CBRN) agent.”Get more details on EUA from here https://hotcopper.com.au/threads/emergency-use-authorization-and-other-approvals.5591703/There’s just too much pressure from the WH.
Regardless of the first interim analysis results, Rem-L will be proven to be working as a solution for Covid-19 ARDS
There is a pressing need to take the fear of death off the table and get the economy moving again.
Rem-L must be approved for EUA, as the bar has been set very low with the existing solutions for Covid-19 e.g. Convalescent plasma therapy
The WH will not wait for the lag time with approval for manufacturing scale-up and the actual FDA approval.
The FDA has to assist here and give us an expedited approval for our proprietary xeno-free technologies solution too.
Put the solution out there, save as many lives as we can and get the economy back to as normal as possible!
The exciting September is coming
Enjoy the ride MSB'ers
(20min delay)