Replies to post #172004 on Biotech Values

[biomaven0]

>>if a drug is safe, it doesn't have to have any indication of efficacy in order to get the go-ahead for a phIII trial from the FDA?

Pretty much. I mean if there was not much evidence of efficacy, the FDA would certainly grumble about it and recommend that the company do some more work on identifying a good population or dosage, but the company doesn't have to follow the FDA guidance on that.

For a good example, read about Burzynski and his "antineoplaston" therapy. Basically a money-making scam, but the FDA allowed him to open a Phase III - I believe a hold was placed on it though before any patients were admitted because of a death in a patient under his care.

Peter

[masterlongevity]

Yes that is true. the fda does not require you to show efficacy in phase 2 to move to phase 3. you are not even required to meet with them. its dumb not to, but you can just send them your phase 3 protocol and wait 30 days to start. if you're not put on clinical hold, you can start a phase 3 without any communication whatsoever. on the other hand, EMEA does require sufficient risk benefit in the ph 2 to allow a drug to move to phase 3