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XenaLives

06/28/20 2:33 PM

#256673 RE: frrol #256666

Be careful, the documents that tell how to apply for it are openly available on the TGA site.

They've been posted again an again.

I shouldn't have to add, I just said it again, the TGA has been involved in this process all along, collaborating with the company to plan trials that will be efficient and provide initial proof of concept in the shortest amount of time. Since the drug is safe "stat sig" can wait until P4.

The company has made it clear that they are working WITH the TGA to get the drug approved.

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McMagyar

06/28/20 4:15 PM

#256685 RE: frrol #256666

They said they would review PA once they had blinded placebo results..
The assumption being that they would be good