Biotech Values

[poorgradstudent]

The FDA does not typically tell companies when it will formally respond to an ANDA and is not bound by any such statements FDA staffers might make.

I have my clear bias as a MNTA long, but in a generally open-ended process like an ANDA, a finite deadline appears more consistent with the sponsor attempting to get something in writing to summarize the FDA's concerns to date (in other words, to try and get the FDA to commit in writing to some type of road map). I would bet that they're going to get a to-do list from the FDA in January rather than a notice of approval. Marth's mention of immunogenicity seems to kinda tip his hand in this regard; he wouldn't have mentioned it if it was not seemingly an outstanding issue.

The other interesting possibility is that Teva's public declaration of a response deadline may signal that they plan to undertake a go / no-go decision at that time. So they either announce the approval at the end of January, or they'll practically stop talking about it from there on in and therefore implicitly guide the street that t-enox isn't really happening.