As a reality check, the FDA approval is not a given.
It is quite obvious from what the FDA has recently shown, that there are other ‘external’ factors at play here that leads to a edge of negativity against the science.
I won’t speculate as to the legitimacy of that negativity or its root source.
My gut feeling is that we will not hear from the FDA until the Covid data is available. They surely would not say no under any circumstances to Ryoncil, if there was the chance they could end up with good Covid results embarrassing them a few days later.
Hopefully it will be a full go and add a label extension, but if Covid looks like a fail, then I have my doubts on their trustworthiness to follow the ODAC vote.
I am cautious , but very excited
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- Ryoncil: ODAC/FDA Meeting Discussion
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