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Re: JPG77 post# 193348

Thursday, 11/11/2021 6:57:38 PM

Thursday, November 11, 2021 6:57:38 PM

Post# of 232961
JPG and C20 - and anyone else - if what we see with Amarex pans out - that is, if it's true they not only failed to properly do their BLA prep work, but they also failed to perform in dramatic/unprecedented fashion - why do you think this happened?

I'm not chumming for conspiracy theories, but I know nothing about Clinical Research Organizations (I had to google CRO to see what it meant), so I don't know how common it is to have such a complete/sustained failure to perform.

Have you heard of a CRO failing like this before?

And in your estimate, how many months has this delayed our BLA submission?


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