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um-tiger

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um-tiger

Re: volgoat post# 226841

Saturday, 07/18/2015 8:37:54 PM

Saturday, July 18, 2015 8:37:54 PM

Post# of 345749
Volgoat and BCS,

From what I was told at the ASM; 1st look-in will be about Safety. No stoppage possible. Why? Because it will be about safety...Q2/Q3 depending on enrollment. 2nd look-in is where the trial COULD be stopped. 2nd look-in will be in 2016. When...is the question?

The new Avid expansion; It will be up and running by December.
Why? Lots of testing and permits. FDA and red-tape California.
From what I understand....The current facility is/will be for clinical testing and is for clinical testing only now. The new facility will be for marketing. Different set of rules per the FDA. The new facility will be 24/7 and will be able to make plenty/enough of Bavi and then some. (I could never get the shelf life of Bavi.)

IMO.

Regards,
Montana
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