NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Hi Sentiment. Just spoke with a friend of mine who is a biotech COO. He agreed with you that you can apply for a BLA without makng it public. Though he said most companies would want to. He said once you had an answer then you would need to make it public. The thing that neither of us could anawer was to get the BLA isn't there a committee meeting open to the public? Or is there some way around this. If someone could answer this question it could put a strong argument against the possibility of a BLA to rest.

Well, if he is unaware of how the Adcom fits into the process, I am not certain how much he knows on the regulatory submission front.

The Adcom meeting is called at the discretion of the FDA. They are expected to call for such on a new drug, but do not always do so. It is public, and purely advisory.

But he says an "answer" would have to be PR'd. If this whole thing is about a BLA being submitted back in Aug/Sep, then they have the answer as they are submitting more information obviously in response to the FDA's response. They were either rejected or CRL'd.