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Re: nidan7500 post# 207118

Sunday, 08/25/2019 9:27:23 AM

Sunday, August 25, 2019 9:27:23 AM

Post# of 462060
This is ridiculous. "Priority review shortens the FDA review process for a new drug from ten months to six months"

I think there should be a requirement for any government employee for a management position should have a minimum of 5-10 years in private enterprise to get real life experience.

Looking ahead, assuming peer reviewed "Nature" didn't make all those mistakes that Investor pointed out. It appears it will be a few more years before the drug would be available for the thousands of afflicted with this horrible disease. I checked out the timeline to obtain an NDA after trial approval.

How long does it take for FDA to approve NDA?

The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe.



Acting secretary of FDA Norman Sharpless, M.D better make some changes in a hurry or FDA will be experiencing the same treatment that U.S. DOT has received.


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