Biotech Values

[zipjet]

imo that leaves only immunogenicity and supply chain issues as obstacles for amphastar, and presumably only immunogenicity for teva

Supply chain. I suspect that this issue is really about qualifying the feed stocks used. Over time there will be shifts in the material supplied by the same supply chain. So testing of the supply is necessary as the product shifts or suffers contamination. MNTA has an advantage but not a lock-out on this factor.

Immunogenicity. This comes up in every case. It caused the delay of mL and still delays tL.

So when will Teva get this right? Why was MNTA able to do this and TEVA not?

Missing November 2007 FDA letter. I will bet that if/when the letter is public that it describes clearly Amphistar's deficiency. That is why the positive content of the letter was described and the letter itself was not attached as an exhibit.

ij