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BioInvestor4

08/14/20 8:48 PM

#106203 RE: daemon57 #106202

They filed request for the Type A meeting with fda last week. Once they get direction from the FDA in this meeting they re file the BLA
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KCRoyal2004

08/14/20 8:51 PM

#106208 RE: daemon57 #106202

I don't recall that he said that BLA was filed, just that they requested FDA meeting, which the FDA has 30 days.
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Dieselpro

08/14/20 8:56 PM

#106209 RE: daemon57 #106202

I haven't read the filing but from what you've posted here could he be referring to the first communication from the FDA about the data sets?
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SammieGo

08/14/20 9:42 PM

#106215 RE: daemon57 #106202

Sorry, reading with tired eyes. As has been mentioned already, isn't the 10k a historical document, for fiscal year ending 5-31-2020? The statements about some of their intentions are now dated and in the past. Right? So, the 10k and Nadar's Wednesday comments can both be true, right?
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Amatuer17

08/14/20 10:04 PM

#106226 RE: daemon57 #106202

Your observation is correct - this is such a big topic - it cannot be typo - it is deliberate and maybe needs an answer from NP.