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inv10001

07/29/15 12:31 AM

#31889 RE: dr_lowenstein #31888

On the contrary, I believe you misunderstand and need to research in more depth. You might start by reading a bit more than the summary on the FDA website of which you reference. The PDF on the same site located here http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf and the table on approximately page 8 might be a good summary. Further, you might search for the list of cancer related drugs that have received accelerated approval if you wish to improve your knowledge.

In no way do I mean to imply that it is a certainty that the combo trial and the 41 patient population will result in accelerated approval. However, if the trial achieves it's results there is a VERY real possibility of an accelerated approval. You might disagree, but probably not if you were one of those who were diagnosed and found that Keytruda and other methods simply had no impact on your survival rate. You might call the combo an unmet medical need and one which demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, and which has a meaningful advantage over available therapies. Of course, that all hinges on the combo data showing what those who are really invested in this stock really hope it shows. Argue all you want, but it will not change what happens in the long term. Good data will = explosive stock price appreciation. Bad data = explosive stock price depreciation.