They settle with 100 million shares.
and ofcause this is my best guess about IND process
I belief that they are stage 2. minor deficiencies that can be corrected it, which where I think why they so hurry to release the 10-k and 8-k to support their OTC market applicaition. Remember OTC market have different process in IND application then any others (all they have to do is list out the ingredient)
will takes few more weeks because BMSN need to fix the deficiencies.
1.Not Approvable Letter Lists the deficiencies in the application and explains why the application cannot be approved.
2.Approvable Letter Signals that, ultimately, the drug can be approved. Lists minor deficiencies that can be corrected, often involves labeling changes, and possibly requests commitment to do post-approval studies.
3. Approval Letter States that the drug is approved. May follow an approvable letter, but can also be issued directly.
If the action taken is either an approvable or a not approvable action (as opposed to an approval action), CDER provides applicants with an opportunity to meet with Agency officials and discuss the deficiencies. The purpose of this "end of review conference" is to discuss what further steps are necessary before the application can be approved. This meeting is available on all applications, with priority given to applications for priority review drugs and major new indications for marketed drugs. Requests for such meetings are directed to the director of the division responsible for reviewing the application.
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