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Re: Amatuer17 post# 193316

Sunday, 05/19/2019 8:06:06 AM

Sunday, May 19, 2019 8:06:06 AM

Post# of 461483
"Large quantity of drug is produced due to manufacturing constraints...

This has been industry practice and does not have to do with any other speculated reasons"

there could be other reasons to speculate:

avxl might need to know that production in large scales does not in some way alter the product;

avxl might want to have large scale runs so that they have an adequate supply "in storage" to properly test shelf life;

avxl might want to have adequate supply to be able to ensure their ability to supply any anticipated or ongoing trials;

avxl might be anticipating an approval with subsequent marketing authorization and want to be able to go to market without delay;

if avxl did not have a manufacturing agreement in place prior to an approval and subsequent marketing authorization then avxl could be held hostage by some manufacturing company who realizes that avxl needs product to get to market and this could adversely impact costs/profit for avxl;

the fda could have requirements dictating larger scale runs in order to ensure good manufacturing practices.

all in all, probably better to be prepared on this front than not.
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