Replies to post #113226 on Biotech Values

[Mbledug Dewe]

Pollyvonwog is the one who posted the response of MNTA IR:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59162901

I was then just curious why did MNTA IR responded that way. That was why I asked the board about it in my first post of today. Meanwhile I did some googling and found out about the elimination of the term "non-approvable letter" by the FDA.

So my understanding is, if FDA's response to TEVA were before 2008, the term used would be "a non-approvable letter" instead of "a minor deficiency letter".

[DewDiligence]

Never mind the semantics—the salient point is that any FDA response to an ANDA other than an outright approval might mean years of further work by the applicant, and ultimate approval is not assured even then.