Let me see, the last ODAC vote on efficacy was 9-1 in favour of Ryoncil approval
Those "idiots" who represented the FDA ODAC panel are not qualified to make such an important vote... or are they?
It was the FDA who elected the ODAC panel member anyway.
- Efficacy was ticked
- Manufacturing was ticked
- Long term survival data was provided
- Evidence of MOA/ efficacy, via Assay Data - was the main problem that resulted in the last two CRL... so the question is what has changed to allow for this Ryoncil BLA Resubmission to proceed?
The FDA could have easily said - hold on you haven't ticked off all the CRL items - this resubmission is incomplete and therefore rejected
But, they didn't!
Why? Something has changed their view. New interpretation of data or new data itself perhaps?
We'll find out shortly - Bring it on!
Tick tock tick tock
GL MSB'ers - onwards and upwards
Cell Therapy News/Articles, page-17939
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