Replies to post #121923 on Biotech Values

[investorgold2002]

Will FDA approve m-C?

you have to rely on

1. FDA took 7 months to accept the ANDA review
2. wheeler's statements in couple of investor cc's that "they think they had everything at the time of ANDA filing in the package"
3. copolymer assay patent. the language confirms to the "ANDA sameness criteria discretion language" (Eg: potency, stability, blah blah for determining product is same as reference product)
4. wheeler said in 2 conf calls that they continue to have positive feedback/discussions with FDA and also said he is not going to discuss content of those discussions...he said he is only concerned about the waiting time with FDA. He used the word confident when it came to completeness of copaxone ANDA filing
5. when asked by ANAL-st on copaxone not having sufficient biomarker
unlike lovenox, wheeler pointed to Peptimmune CP and said it is possible. it is also i believe in this context he said he is having positive discussions without disclosing details.
6. Copaxone is 40K treatment. I am sure FDA would be inclined to approve generic and may even give it a priority review, once patent case is resolved...prolly just like fondaparinux review...