re teva comments on enoxaparin today:
you pretty much summed it up. for those interested it was in response to a question about the apparent delay in enox approval (amusingly the questioner referred to it as M-enox, i.e. momenta's version), and Marths' response was more or less as follows:
"we continue to dialogue with the agency and were told would get an answer...what will that answer be? [it could be] gee i need more information regarding immunogenicity, it could be that. It could be more complicated answer. could be approval...it is being reviewed by OBP and we have been promised an answer"
this is what i glean from this answer:
1. TEVA has not yet gotten a pass from the agency on immunogenicity
2. the fact marth raises the specter of a "more complicated answer" means it is not entirely clear immunogenicity is the only issue still outstanding in the application (or else anything other than immuno wouldn't be a possibility)
3. the Q1 guidance is real, based on agency feedback that they will hear by the end of jan, and could be anything from approval to a short delay, to a major delay with their application
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