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Re: DragonBear post# 104690

Monday, 10/21/2019 9:32:33 AM

Monday, October 21, 2019 9:32:33 AM

Post# of 144812
Bearspread, if you are gonna keep bringing this up .

EMA did grant Austrianva a Phase 3 trial ( based on the earlier P1/2 Lohr trials ) . The P3 was gonna have n= 200 patients

apprx $40mm was raised to conduct the trial slated to begin in 2007 / 2008

High tech infrastructure to support the trial back in those days was not quite ready , and one of the major funders decided to pull out.

Austrianova paid back almost all the funding money , but could not pay it all back as several $ million had been spent , as the EMA would only grant a P3 if production was in place . If memory serves me correctly , AN spent apprx $6mm building the one-off encapsulation machine . This machine has since been improved and a newer version has been built .

So , here we are today , and NOW infrastructure does exist to support our trial . Ken W has had to travel and get previous trial docs from Bavarian Nordic , and get certain entities to sign off and allow us to use Lohr's data .

I expect you already know this . PMCB did have a pre-IND meeting with FDA , and we got a long list of testing to conduct , and if successful , FDA would grant our trial . Hold on , we're about to find out

Go PMCB + AN + Primegen + Thermo Fisher + cGPM,LLC + Facet Life Sciences , and finally Dr. Manuel Hidalgo . Quite the TEAM , IMO
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