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Alias Born | 01/06/2017 |
Monday, September 02, 2019 9:45:11 PM
The FDA will either approve a pharmaceutical drug, or clear (via a 510k or PMA) a medical device
they will never flat out write a letter that says that they have “failed” a drug
Go ahead and search their database for that letter. The PR is essentially saying to the public that they are pulling their effort for FDA approval
The company could do 50 different FDA trials on several endpoints if they had the money. They choose not to go any further
Anyway, I gotta go to bed for a regulatory affairs on tomorrow. Posting is not my full time job. I just wanted to call you out.
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