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FDA does not over-rule positive ODAC decisions, page-5

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Younginvestor01

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30/09/20

13:01

Post #: 47737923
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Originally posted by bedger: ↑

There's been a little discussion of wider figures on FDA approvals following Commission decisions. A study from 2016-2019 shows that the FDA has NEVER over-ruled a postive ODAC decision for a drug/treatment approval in recent times:

https://www.mayoclinicproceedings.org/article/S0025-6196(19)31041-9/fulltext

"There were seven (11.5%) instances when the FDA approved a drug after ODAC voted against it; 1 instance where ODAC was evenly split on their decision and the FDA approved a drug; and 0 instances when the FDA rejected a drug approval after ODAC’s recommendation to approve. Twenty-five were unanimous votes either in favor (n=16) or against (n=9) an approval (Figure)".

Do you really think the FDA is going to vote down RYONCIL (REM-L) given there are no pediatric treatments available? I would put this vote at 95%+. The 5% is only due to the political coercement that appears evident in some of the FDA's more recent poor decisions.

Sell today by all means to reduce your risk exposure, but you will very likely be paying far higher tomorrow to get back in.

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Comforting words, I like you a lot.

MSB Price at posting: $5.15 Sentiment: Buy Disclosure: Held
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FDA does not over-rule positive ODAC decisions, page-5

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FDA does not over-rule positive ODAC decisions, page-5

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