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Re: ArchieK post# 345102

Tuesday, 12/12/2023 3:05:26 PM

Tuesday, December 12, 2023 3:05:26 PM

Post# of 347009
But they did have customers prior to expansion. Nick's question response makes that clear.

And I think that, for those of us that are in the market on a day-to-day basis, is that that take that there’s just unfortunately a natural time phase that that takes to execute and once you’ve completed the PPQ campaign, you have to file that data along with the clinical data to the FDA and get approval and then the commercial volumes come.

And of course, one of the other issues is, of course, nobody’s going to put a PPQ campaign together with a supplier that doesn’t have that capacity to meet the commercial demand.


Later on he says

And actually, we couldn’t have asked for a better situation than we’ve got right now, which is that as we’re concerning one of those in, they’ve already got approval. So that’s about as fast as it ever goes. So looking forward to that one


The real question is how many companies are behind the BLAs? It could be just one.

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