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Northstar42

08/17/18 12:08 PM

#27107 RE: gestalt2 #27102

Gestalt2 great post. You have summed up the situation perfectly.

tommyterrific

08/17/18 12:48 PM

#27109 RE: gestalt2 #27102

I agree

Amatuer17

08/17/18 2:18 PM

#27111 RE: gestalt2 #27102

If you have seen many drug approvals - they have 2 pivotal trials - 1st trial and 2nd confirmatory.

This is done even after dose is optimized. The current trial was never defined as pivotal and they changed the dosing - so most likely final dose pf 700 will have only handful patients. FDA will not approve a drug based on such small trial of new dose.
So I still maintain that CYDY will need a full pivotal trial with final dosing - most likely 700 mg. So I consider mono approval to be in 2021

I agree that they could be bought before the final results. However it may not be based on HIV indication but based on some preliminary results for one of the cancers