Biotech Values

[RockRat]

>>Teva is the world’s leading authority on the API side of the pharmaceutical business. I doubt that their Lovenox non-approval relates to deficiencies in the supply chain.<<

I was not referring to the suppliers of their source material, apparently a stumbling block for Amphastar. I was referring to the manufacturing process itself. The 1,6 anhydro ring structure is very sensitive to process parameters such as the temperature, pH, depolymerization time, etc. I'm not sure if that is the technical difficulty that has slowed Teva down or something else, such as the fragment mapping, the sequence of the oligosaccharide species, or what. It would be great to get someone with sufficient technical expertise to go over the FDA's reply to Sanofi's CP, released Friday, and tell us which is the hardest part. I am not that someone. But while Momenta has published plenty on these subjects, Teva has not published a thing. I've looked. So maybe somewhere in the footnotes of the above mentioned document is paper by Momenta scientists describing, to some extent, a technique critical to convincing the FDA of approvability that Teva has not yet been able to match. I'm still going to try and drill into those, to the extent that I can, but I'm not buying every one of those papers, and as I said, I'm no expert. But I don't know if we're going to get one to help, so that's all I can think of to do. I'll post if I find anything that looks like a clue.

Regards, RockRat