Biotech Values

[pollyvonwog]

Today on Oppenheimer call Craig Wheeler was asked if MNTA was notified by the FDA prior to approval if they had met a sameness criterion.

CW's response: "We thought we were notified many different times about many differnt things during the process. What we learned the hard way is that there are not really seperate approvals. You don't meet one unless you meet the other. Part of your question comes from TEVA's comments that they met sameness but are still dealing with immunogenicity. Well, I think the way we found the agency dealing with is that if there is a difference in immunogenicity then its not the same drug so you're not the same. It is not as compartmentable as a traditional generic where you get through bio and check the boxes. It is a much more integrated view that the agency took, at least of our approval. So I don't think any any point we could say we met this but haven't met this because we were finding that the interplay with them was actually quite strong."