I see what you're saying, those are the discussion points raised by the FDA to ODAC. I can't find online what ODACs solution to that was, but I guess since they voted for it they were less concerned about the potency assays?
I'll dig deeper to see what ideas ODAC had with regards to solving these problems. I can't find their response.
I'm willing to admit I was wrong about ODAC, seems what I posted were the FDAs concerns.
I think the key thing is though at the end of the day, we've seen it's the FDA that makes the final call, and they've been very clear as to what they need to approve the product.
MSB knows what it needs to do, and hopefully it's making progress towards it.
MSB Trading 2021 - paradigm shift, page-7845
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