GLP results coming up which are already de risked and then we move into phase 1 and Walter reed which is derisked from 2012 pre clinical study then FDA submission in Feb and then phase 2 with funding from the US defence force.
You have made every single thing up.
The US Army aren't paying for a stage 2 trial. Christ alive, Walter Mitty would turn in his grave.
FDA submission??
What are you submitting mate - do you know?
I'll tell you -
you are asking them for permission to do a human trial. An IND application.You are not de-risked. I don't know why I'm bothering as all you do is keep repeating the same silly things over and over again.
https://www.fda.gov/media/82381/downloadYou are at stage 1 of 12 steps
It clearly states:
Trial cohort numbers
Stage 1 - 100 patients
Stage 2 - 300 patients
Stage 3 - 1000+ patients.
You are at the very beginning of the FDA journey, and as I've pretty much shown you to be a bloke that has absolutely no idea what he's talking about, I'll leave this here.
To everyone else - here is the journey ahead - you are at Stage 1 on a 12 step journey that will take 10+ years.Please read THESE:
https://www.fda.gov/media/82381/download
It takes 10 years minimum from where Nyrada is now to gain approval - often longer:https://lifesciences.n-side.com/blog/what-is-the-average-time-to-bring-a-drug-to-market-in-2022Lastly - you know how many drug start-ups that fund these trials themselves?
1 in 1000 - yes, that's all - 0.01%
You aren't going any further on this journey without a big pharma company. You are about $200,000,000 short of funds.
Best result would be a 50% share of the company in exchange for trial funding.
Worst - they buy you out when the SP is at rock bottom.
AGN has nothing to do with this.
$10,000,000 in the bank has nothing to do with this.
Read the FDA info mate and stop telling porkies to people - you have absolutely no idea what you are talking about, and some people here seem to think you do. You don't.
(20min delay)