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RockOYates

Pick up a copy of Rick Ng's Drugs: From Discovery to Approval. It will help.


After a Phase 3, if the drug is approved, does the drug still have to go before an FDA Adcom?

This statement is not correct. After a(or a few) phase 3 result(s) is available, the advisory committee gets involved and makes a recommendation on approval. This is a pre-approval step. The FDA does not necessarily have to follow the recommendation of the advisory committee, but often does.


I've no interest is your investing strategies, but if they aren't even based on an understanding of the process they are not likely to be useful.


IBB is a poor proxy of the industry due to its composition and weighting.
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