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genisi

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genisi

Re: DewDiligence post# 141441

Monday, 05/07/2012 4:38:01 PM

Monday, May 07, 2012 4:38:01 PM

Post# of 252254
Novartis does not generally comment on the filing of an NDA for low profile drugs so we'll probably won't be able to find their answer but I don't think the withdrawal of NDA for SOM230 is related to the LAR formulation. The LAR formulation trial in Cushing's is few years behind and they still have ongoing trials with the S.C formulation so my guess is NVS will re-file with added data from those trials. Btw, they filed in the EU in late 2010 and approved in early 2012, isn't that a bit long?
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