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I'll also add that the additional ask regarding

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BlackDoggie   Friday, 11/10/17 11:37:33 AM
Re: BlackDoggie post# 18097
Post # of 32022 
I'll also add that the additional ask regarding patients for safety data may appear out of line with that reasoning at first blush. However, if I'm the FDA, and I'm agreeing to consider labeling more broadly than for a very small subset of very sick patients, I might want more safety data to justify it. Basically, if the company wants to market the drug (via the combo application) to a patient population that is less gravely ill than the patients they were originally restricted to, then the FDA might reasonably want more assurance that the drug is safe to offer to patients who may have options.

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