Tuesday, June 28, 2016 1:27:01 AM
The FDA is required by law to keep the sponsor's information confidential prior to approval. There are a few clear exceptions, such as the Adcom meeting.
This has nothing at all to do with what a company does elect to make public.
If your point is that the FDA would not "leak" a submission, I agree. But the post you replied to mentioned hundreds outside of the FDA that would not be covered by any such,
Regardless, the entire "BLA has been submitted" concept is such a joke. It truly amazes me the degree to which some construct complete fantasy worlds to support the investment logic.
BTW, Any further comments from Les about his statement that the investigation would be "soon" based on the 90 days estimate? That was about 3 months ago he said that, and "soon" with that context should have been weeks.
Did he lie, or did you miss understand him again?
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