Biotech Values

[exwannabe]

Re: ' So, in theory, all companies sending in applications for approval "think" or "told investors that they think" they have met all FDA requirements '

This is a unique case, the FDA is approving a quasi-biologic (sorry DD) for the first time. And the response to the CP does outline a lot of the basis.

I doubt reality is as black/white as Rat's statement, based on the tendency of companies to be sloppy in public statements.

But I would bet hard that Rat is better qualified than anyone here to decide how precise the FDA recs are in this case.

So if Teva was delayed 1-2 months on submitting the imuno. data, I would put a small risk factor TEVA gets an approval next month or two.