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lovethatgreen

12/09/23 4:22 AM

#168566 RE: lovethatgreen #168564

I've re read last update Oct 11th several times and I see the doc referred to next quarter as q4 in a paragraph. So , logic could dictate all the rabbits will have been tested sometime this month if not already . Thinking he wrote this in Sept

What more could the fda pull out of its ass for further testing ? I'm thinking they have run out of runway for more animal tests .If they submit by March we could see approval no later than 30 days from time of submittal . Maybe , we get lucky and they submit earlier.

How long does it take to write a report ?

VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data to Pearl Pathways for independent review, and write the report.
Genotoxicity – Based on the FDA recommendation; on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty Chemical Characterization Protocol (GCCP). We now feel sufficiently confident to initiate the genotox testing next month (October–November 2023).

Truthsocial

12/09/23 6:01 AM

#168567 RE: lovethatgreen #168564

Guaranteed IDE submission and approval is much sooner than most believe imo.
With rabbits and genotoxicity testing completed this month and Mayo clinic IRB prepped and ready to go end of this quarter. Seems to be a logical next step IDE APPROVAL for RDGL clinical trials sometime in 1st quarter....imo providing FUDA doesn't do a last minute change up....
Bullish
Bullish

kayak_wench

12/09/23 11:35 AM

#168568 RE: lovethatgreen #168564

Given the company update topic was q3 it should be appropriate to think 'next' refers to q4. It also wouldn't make much sense to do nothing for 3 solid months before starting additional testing further supporting the conclusion the 'next quarter' in the last update was in reference to q4.

So while no one can can anyone answer that with 100% accuracy except Mike K, common sense indicates it was q4 2023.

DomerJon

12/09/23 11:51 AM

#168572 RE: lovethatgreen #168564

Great question for RDGL really. One can read it either way, correct? You would hope this next quarter is the answer, but being in the 3rd qtr when it was posted, it could also mean Q1 24.