Biotech Values

[akasidney86]

I don't see any confusion or obfuscation in Schlomo's statement... it's very straight forward:
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"We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets teh FDA's criteria to demonstrate chemical sameness and accordingly that data related to immunogenicity are currently under review at the office of biological products."
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The questions regarding that statement, IMO, can't be about what he meant... that's very clear. The questions can only be about credibility, and given the speakers position and the companies seriousness, it's difficult, at least for me, to discount.

To the credibility question: is this something that the FDA would do? State to an applicant 'Yes, you've checked the sameness box, so now we're passing you on to immununogenicity...'? I don't know from personal knowledge the answer to that question, but from what I've seen looking in from the outside, would doubt.