Thanks @
DoriansMirror and @
MilesCC ,
I have same thoughts, but it worries me that all these reports i see on a regular basis, point this out as if it were a weakness.
"The COVID being a major problem" is the very reason the big Pharma will not let go of this so easily. When you have such a great sure shot product, the big pharma will come out with guns blazing; if the cant stop it, they will try to delay it.
The ODAC meeting showed that it isnt enough to just have a great product, and there are other aspects to be covered as well. Maybe a bunch of insights into current Temcel plants...some data on batch qualities from JCR's manufacturing, comparison of consistency in qualities for the industry (if there are any benchmark parameters...)
Christian hinrichs, the FDA guy, who voted against MSB said this - "With a complex and somewhat unclear mechanism of action it's really difficult to think about how you would want to see the potency determined, and what mechanism characteristics you would want to see tested,"
Let alone me, I am sure as hell, even he cannot explain wtf this means. If a small market for aGVHD had this kind of opposing argument, COVID-19 will face a much stiffer test.
Anyway, I am neither an insider or an expert, and trust the defense strategy will be great.
If the Aug 13th ODAC MSB showcase is any indicator of future defenses, then there is probably nothing to worry about.
GLTAH
(20min delay)