InterMune (nasdaq)ITMN Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : InterMune (nasdaq)ITMN

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: ghmm who wrote (462)	2/3/2009 1:09:05 PM
From: Biomaven	Read Replies (1) of 508

Looking at this data across time (rather than just the 72 week snapshot), it's clear the drug has efficacy. I'd say an advisory committee composed of clinicians would definitely be supportive of the drug; I can't predict how the statistically-oriented folks on the panel will react. Specifically, the Repeated Measures Anlaysis which looks at the primary endpoint at each measurement date (slide 18) shows both trials showing stat sig efficacy (.004 for Cap-1 and .001 for Cap-2, and <.001 pooled). There are certainly some oddities in the data - for example, the six-minute walk secondary endpoint was hit (.001) on the trial that failed but missed (.171) on the trial that succeeded. > I don't know why they didn't stress baseline FVC in Cap-1 Pirfenidone is 74.5 vs 70.3. Not sure what to make of this - the drug patients were less sick in Cap-1, but given you are looking at progression, not sure exactly how that cuts. Technically they have 2 successful trials if you include the Shinogi data, and so maybe they meet the technical FDA requirements for approval. I bought a little this morning - no position before today. Peter

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next