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HDGabor

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HDGabor

Re: Biobillionair post# 106907

Friday, 05/26/2017 7:11:23 AM

Friday, May 26, 2017 7:11:23 AM

Post# of 423943
BB-

SPA rules are based on law; once an agreement is reached it can not be changed because of opinion ... SPA is to prevent moving bar scheme

it can not be changed - FDA may rescind an SPA agreement ...
because of opinion - the division director determines ...
once an agreement is reached - after the trial has begun ...

The basis of your view - substantial scientific issue essential to rescind an SPA agreement - is false, you do not interpret the law correctly. It is B&W: "substantial scientific issue essential to determining the safety or efficacy of the product" ... means available science is not enough to determine the efficacy without any doubt.

Best,
G

#NEWMIAMI

Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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