Biotech Values

[dewophile]

re FDA response

it looks like much of the veil surrounding the lovenox applications may be lifted with the FDA response. i would go as far as to say this response may constitute a major binary event for the stock. If the FDA admits that amphastar has met the 5 criteria outlined in the response to sanofi's CP, and in fact the only hurdle that remains is related to the supply chain (as implied by the complaint), then this would be quite bearish. conversely if the FDA states the sameness criteria back on 2007 did not relate to a more rigorous set of standards put forth since then, it could provide a significant lift. i might even say that it gives me more confidence that TEVA's application has not met the 5 criteria since they were very careful to use the term "chemical sameness", which can be construed to mean they met the first criteria of the 5, which is "equivalence of physiochemical properties". Granularity on the immunogenicity issue could also cut both ways. as i noted in my prior post, differences in immunogenicity between lovenox knockoffs and branded have been identified that are due to differences in the composition of the compounds themselves (irrespective of external contaminants). this would explain how amphastar can achieve a high degree of "purity" but still be immunogenically different (of course this would mean that they haven't met the 5 criteria or else there would be no structural differences that could lead to differing immunogenic profiles). again the language here - particularly since TEVA admits this is where the application is hung up - could have implications for how the street views TEVA's chances

jmo - i know many of you play options but i woudl be careful entering feb if indeed a detailed response from the FDA reaches the public domain