https://www.ich.org/page/members-observers Hell
Post# of 36573
(Total Views: 461)
Posted On: 04/27/2021 8:57:34 PM
https://www.ich.org/page/members-observers
Hello all, I was out of pocket today and just saw the PR. I have posted a link to the ICH page and if I had to guess at what happened, GNBT consulted with USFDA and chose to use ICH for their trial populous as it will provide the most robust data source as NGIOs “Complete Vaccine” will be given to diverse patients populations across geographic, demographic and disease state/varied virus mutations. This is the most exciting part to me as I looked them up and saw the the good ‘ol USFDA is a founding regulatory partner along with other prominent countries’ regulatory bodies.
Once NGIO gains data back from these trials it will be seen as the most credible and robust information that could be collected. This is actual good news. Also as RJ astutely pointed out that GNBT’s Chinese partners will be covering the tab on these proceedings.
This PR fulfills:
1. Showing forward momentum
2. Showing a commitment to credibility and gaining quality information that will be valuable for the long term
I agree that we need an IPO on top of this to be able to maximize the PR gains from an IND acceptance and subsequent trial results.
Hello all, I was out of pocket today and just saw the PR. I have posted a link to the ICH page and if I had to guess at what happened, GNBT consulted with USFDA and chose to use ICH for their trial populous as it will provide the most robust data source as NGIOs “Complete Vaccine” will be given to diverse patients populations across geographic, demographic and disease state/varied virus mutations. This is the most exciting part to me as I looked them up and saw the the good ‘ol USFDA is a founding regulatory partner along with other prominent countries’ regulatory bodies.
Once NGIO gains data back from these trials it will be seen as the most credible and robust information that could be collected. This is actual good news. Also as RJ astutely pointed out that GNBT’s Chinese partners will be covering the tab on these proceedings.
This PR fulfills:
1. Showing forward momentum
2. Showing a commitment to credibility and gaining quality information that will be valuable for the long term
I agree that we need an IPO on top of this to be able to maximize the PR gains from an IND acceptance and subsequent trial results.
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