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Re: finesand post# 38023

Saturday, 03/02/2019 6:15:56 PM

Saturday, March 02, 2019 6:15:56 PM

Post# of 232914
I tend to think that enrollment isn’t an issue, but getting every last detail of the trial procedures is probably extremely important. Remember, Pestell seemed surprised at how quickly the FDA approved the IND. This needs to be done 100% correct the first time - I doubt the patients are the hang up.

Otherwise, you end up in the situation we’re in now where we need more data from mono patients for HIV to support the combo BLA, because they failed to do a proper dose escalation phase in combo from the start.

Maybe that’s semantics (enrollment vs. getting the details right), but it makes a difference to me after the difficulty enrolling the combo P3!
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