Biotech Values

[iwfal]

even so is this based on Amphastar's assertion in its complaint that they were told they satisfied the 5 criteria (by phone, letter, carrier pigeon, etc). If so, it will be interesting to see exactly what the written communication said, was it hedged with weasel words such as "preliminary", "subject to further review", etc.

I agree that it probably does have some caveat - but I was focusing on other things that are of more interest to me since I think the chance of Amphastar winning are small. The more interesting data to me are, among other things,:

a) Any reference to additional testing/criteria/... (e.g. immunology) or organizational review

b) Any evolution apparent in 'sameness'

In total I don't believe that the Amphastar case has much chance - but I do think that it will shine a light on the process. Really provide a lot of data on how FDA works for generics - and that will provide handicapping info on Teva's assertions.

FWIW - Bow to Dew - In sorting through many of the past messages related to this I think Dew has had a reasonable and reasonably consistent handle on the processes that I am only now (with the Amphastar data and resulting impetus) coming to understand.