I had an email exchange w Joe earlier. I had a fo
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Posted On: 09/28/2020 2:49:12 PM
I had an email exchange w Joe earlier. I had a follow up Q, so I hadn't posted yet, but here is what I had so far, and it seems to jive w what RJS is saying about the protocol approval:
Me:
Can you clarify the regulatory approval approach for the vaccine in the Bintai deal? I had understood that NGIO/Bintai would be directly pursuing the vaccine and its approvals in Malaysia, then expanding to other countries in Bintai's regions.
In this article today, Bintai is quoted that FDA approval would be the first, then they would approach the Malaysian authorities.
"After Generex has received the full FDA approval on the vaccine and provide full documentation to Bintai Kinden, Bintai Kinden will commence the registration process with [Malaysia's] National Pharmaceutical Regulatory Agency for the vaccine," Bintai Kinden said.
Bintai Kinden, IJN sign MOU on Covid-19 vaccine development
I guess I had thought Bintai was not only providing funding but expertise as NGIO/Bintai sought approval directly in Malaysia, as maybe this was a faster path to having an approval in our pocket to show the FDA and others.
Thanks for any thoughts!
______________________________
Joe:
I do not know anything about this they did not show this to me prior to them putting this out, but this is wrong, once the blood screens and the assays for off targets, antibody production and long term memory are done and confirmed and then we have a vaccine, the iikey peptides that give the best coverage, the bcell epitope and the adjuvant in one vaccine the trials will be done through our previously announced jigsaw cro in Malaysia, then they will conduct the trial work once their fda weighs in and clears our pathway. They simply got it wrong.
_______________________________
Joe again (couple minutes later):
Unless they meant after we get our fda approval after all the assays and bliss (I assume he meant "blood"
screen work and get our ind approval here we get our ind approval there, only thing I can think they meant.
_______________________________
So presumably we would get the FDA protocol approved, then move forward in Malaysia, on Bintai's dime, planning to use any data for US FDA approval...
Does that make sense to you more trial-savvy guys?
Me:
Can you clarify the regulatory approval approach for the vaccine in the Bintai deal? I had understood that NGIO/Bintai would be directly pursuing the vaccine and its approvals in Malaysia, then expanding to other countries in Bintai's regions.
In this article today, Bintai is quoted that FDA approval would be the first, then they would approach the Malaysian authorities.
"After Generex has received the full FDA approval on the vaccine and provide full documentation to Bintai Kinden, Bintai Kinden will commence the registration process with [Malaysia's] National Pharmaceutical Regulatory Agency for the vaccine," Bintai Kinden said.
Bintai Kinden, IJN sign MOU on Covid-19 vaccine development
I guess I had thought Bintai was not only providing funding but expertise as NGIO/Bintai sought approval directly in Malaysia, as maybe this was a faster path to having an approval in our pocket to show the FDA and others.
Thanks for any thoughts!
______________________________
Joe:
I do not know anything about this they did not show this to me prior to them putting this out, but this is wrong, once the blood screens and the assays for off targets, antibody production and long term memory are done and confirmed and then we have a vaccine, the iikey peptides that give the best coverage, the bcell epitope and the adjuvant in one vaccine the trials will be done through our previously announced jigsaw cro in Malaysia, then they will conduct the trial work once their fda weighs in and clears our pathway. They simply got it wrong.
_______________________________
Joe again (couple minutes later):
Unless they meant after we get our fda approval after all the assays and bliss (I assume he meant "blood"
screen work and get our ind approval here we get our ind approval there, only thing I can think they meant. _______________________________
So presumably we would get the FDA protocol approved, then move forward in Malaysia, on Bintai's dime, planning to use any data for US FDA approval...
Does that make sense to you more trial-savvy guys?
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