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Re: GrthzGd post# 174052

Tuesday, 02/11/2014 3:20:36 PM

Tuesday, February 11, 2014 3:20:36 PM

Post# of 257579
MNTA—I'm referring to a different exchange later in the CC (from #msg-97088200):

Ronny Gal (Bernstein): And last but not least…the anti-TNF that you got coming into the clinic this year. …what I am hearing you telling me…is that you are doing what you think is a global registration program, but you’re doing it after getting clear guidance from EMA, while your guidance [from] FDA might not have been as clear as you would like it to be?

Craig Wheeler (CEO): Well, we didn’t talk at all about the guidance we’ve gotten from either organization… but in Europe you…don’t have to have a full read on the program [to start phase-1] and that’s one of the advantages of Europe. So, I did not comment on what we agreed either in the EU or the U.S. in the discussions, but we are intending to enter the clinic through that route.

Wheeler did not deny that M923, the compound being discussed in the above exchange, is an anti-TNFa drug, thereby implicitly confirming that it is. Since M923 is certainly not Enbrel and is very likely not Remicade, we may infer that M923 is Humira.

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