If you agree we are the leaders in Regenerative Medicine, and FDA reject us on manufacturing, surely they realise what that would to to the global cellular therapy sector. It would set it back years, not to mention the NASDAQ reaction. Is any competitor in any better position than us on this issue? Novartis wasn't, got quizzed on it but still got approval. The more I think about it, the more I see this as FDA going through the motions albeit with bravado. A necessary protection of their butts.
GLTAH!
PS It's gonna be a long night tonight. Lucky it's bin day Saturday. Fingers crossed, see you later.
FDA ODAC Meeting Material discussion analysis, page-367
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