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BlackDoggie

11/10/17 11:37 AM

#18098 RE: BlackDoggie #18097

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.

ahab333

11/10/17 3:28 PM

#18104 RE: BlackDoggie #18097

BlackDoggie's partial quote I want to reply on:
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" Worst reason I could think of - since data could not have been evaluated and we have no notice of severe adverse effects - would be the FDA colluding with BP to delay development "
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One never knows what big pharma can do when faced with very strong competition with a drug that they have. I am very serious posting this because it is a strong possibility for a big corporation to styme an ongoing new drug like Pro-140. I wouldn't doubt it could be done and wouldn't doubt a government agency to accept, well you all know what I'm trying to say here but I won't. Big eyes could be watching everywhere - GLTU and all longs

HCIT