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ariadndndough

08/31/12 2:33 PM

#148032 RE: biomaven0 #148030

peter i assume this bodes well for ponatinib
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Summer2762

08/31/12 3:03 PM

#148036 RE: biomaven0 #148030

Does anyone know how to find the application number of an NDA?

I am looking the FDA medical review docs of enzalutamide. These should be public by now.

Something like the following but for enzalutamide

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000MedR.pdf
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mcbio

09/01/12 3:31 PM

#148062 RE: biomaven0 #148030

That was quick - about a month after the FDA accepted the NDA.

What's the current status of the private company, Aragon, that thinks they have a similar, but even better, drug than enzalutamide, albeit much further behind (#msg-69072049 )?
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DewDiligence

09/01/12 3:39 PM

#148063 RE: biomaven0 #148030

It took twice as long as Gleevec, which the FDA approved in only six weeks :- )