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Re: The_Q post# 40669

Monday, 11/01/2021 7:43:08 PM

Monday, November 01, 2021 7:43:08 PM

Post# of 43813
1. They’re going to try to announce a bla update and the peer review either concurrently or right after each other so the shorts can’t say anything bad about the peer article. In other words, if the bla makes progress, then any Data must show sufficient option for submitting for approval, the preset data submission is legitimized

I had hoped they would have announced the feedback from the pre-BLA meeting, but I don't think they will do that any more. I suspect that meeting has already happened and since we haven't heard anything, we most likely won't. Geert doesn't care about the shorts for the time being. He doesn't need to raise money until 2023 so the short-term SP is irrelevant. We should have some sort of positive catalyst before money is needed.

2. The buyout could be silent and may have already happened. The big company does this so to avoid bad PR if the approval doesn’t go through

No. Once a buyer and seller have agreed on terms, there is no need to wait. An announcement would be forthcoming. Instead of being quiet if an approval doesn't go through, a BP would just wait to make an offer until after a BLA acceptance announcement. BP would rather pay a lot of money for an approved drug vs. take a risk on a drug that might not make it through approval. Also, just because a company receives a CRL, doesn't mean the drug is finished. The sponsor often fixes the errors (as long as it's not trial related) and resubmits.
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