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jq1234

01/06/11 2:18 PM

#112034 RE: dewophile #112030

"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"



What a difference from his previous comment!
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jb_118

01/06/11 2:32 PM

#112040 RE: dewophile #112030

Re: Bill Marth on t-enox

A couple of other thoughts:
I would add that he said they are told they will get an answer by the end of January.

This is interesting because people have publicly wondered if TEVA would just keep the answer quiet and string things along if the FDA asked for more data. Now they are locked in to reporting what the FDA says, good or bad.

In response to another question, Marth noted that the general counsel was there to keep him in line in his responses (said light heartedly, but still noteworthy that he was there). The admission that the FDA might want more data, and further that it might even be something substantial, was a first as far as I remember.

Clearly he didn't want to talk about t-enox. They didn't talk about it at all until finally an audience member asked, and it was the first question from the audience if I recall. As soon as Marth was finished, the GS analyst took over and redirected the line of questioning.