Replies to post #111620 on Biotech Values

[mouton29]

"And more importantly, will and when we see an FDA response?"

I'm doing this from memory (on a 'berry), no access to the docket, but I believe when the Couirt granted leave to amend the complaint, they set the due date for an answer in late February

[dewophile]

i hope the company clarifies when the 5 criteria were in fact put forth long before we wait on the FDA's response. they are presenting as far as i know at JPM again so there's an opportunity. obviously if amphastar met the 5 criteria then i agree with peter assessment that teva's claims gain credibility (although immunogenicity hurdle still looms). it would have been nice to have the letter as an exhibit. it's omission, like your point about immuno being part of the criteria that by their own admission they have not yet met, all lends credence to the notion that they did not meet the 5 criteria back in 2007, but it would be nice to get confirmation

[biomaven0]

FDA current 5 criteria in '06 when those require the immune data that had not been presented until later?

Actually immunogenicity is not one of the five criteria for sameness. If I recall correctly, immunogenicity was kind of an "add-on" to the other criteria.

It is certainly possible that Amphastar was told they had met "sameness" early on, and they extrapolated this themselves to the claim that they had met the five criteria.

Peter