Beasley, thank you for posting this, and this is a
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Posted On: 11/02/2020 1:09:01 AM
Beasley, thank you for posting this, and this is an interesting article, although slightly misleading to the actual amount of $$ going to the company in the short term which is stated at the end of the article. I for one believe that it is perfectly fine that BARDA has not allocated funds for GNBT/NGIO. It would certainly make it an easier pathway short term, but it may also serve to limit the scope of the reach of the NGIO created vaccine, and unless it is a significant sum ($150MM+), it may not be worth taking it if NGIO has strong interest in delivering OUS.
It is also likely that BARDA decision makers are all-in on the MRNA/DNA/RNA tech which WAS a sexy choice 4-6 months ago, but is fading due to no T-Cell response and not recognizing other key factors. Plus logistics are simply not realistic to maintain high quality and consistency within each dose due to the specific temperature requirements.
There do not seem to be many dynamic mindsets at the govt science levels in my readings, and less as part of Trump Admin unfortunately, so it appears that there has been serious amounts of group-think happening. I do think though that if Trump actually saw what was happening at NGIO, he would at least be interested in including them in Operation Warp Speed as even a backup-plan. I just think that no one knows about GNBT/NGIO at those levels. Perhaps a Trump/GNBT supporter could alert him to our shiny object that is about to be the sexy new thing...I hear he sometimes checks Twitter...
Let's talk about how this could happen in the case of the small plasma company in the article...
If the small plasma company had FDA clearance already, and was in production on a contract basis elsewhere, this would be a very realistic award as the company would have had a commercialized product and simply just need to scale its facilities to meet demand. It is also possible that the address on file with BARDA and FDA for the company is the person's home address and that company maintains the design history file either by an outside consultant or electronically themselves ensuring that the company is compliant to the quality standard set forth by the FDA for reporting and other responsibilities. While this is not super common, it does happen especially when the contract mfg is abroad. (Please note: I am completely naive when it comes to specific regulations on blood plasma products)
Given the amount of funding is only $750,000 it sounds like the small company is getting the funding to perform a "proof of concept" for commercialization, and will then gain some additional funds in a series that may add up to $63MM once they are to scale. I am also dubious though about the $63MM being earmarked and the alleged close relationship between the company owner and Santorum as well as other key figures in the process. One would think they would excuse themselves from the process after sharing their views/potential ownership conflict and let others vet the company based upon merit. I think the article does attempt to highlight this that the Dr. Kadlec character does not have direct affect on the process, but it should explain the situation better so that it is clearer.
Getting back to NGIO, I believe that we may be pleasantly surprised by the funding matrix that is being setup, and may offer the most flexibility in scientific pursuits and commercialization. If NGIO is able to not have golden handcuffs affixed in the immediate future. Would be a lovely problem to have though sometime in the short term, or medium term future and would certainly help drive interest to the NGIO IPO
If I were involved with NGIO directly, I would recommend they sign as many OUS deals as quickly as possible so that perhaps those deals could be "grandfathered" for a specific term prior to BARDA funding which may come with tentacles and limitations about where and when the fully developed vaccine can be made available.
It is also likely that BARDA decision makers are all-in on the MRNA/DNA/RNA tech which WAS a sexy choice 4-6 months ago, but is fading due to no T-Cell response and not recognizing other key factors. Plus logistics are simply not realistic to maintain high quality and consistency within each dose due to the specific temperature requirements.
There do not seem to be many dynamic mindsets at the govt science levels in my readings, and less as part of Trump Admin unfortunately, so it appears that there has been serious amounts of group-think happening. I do think though that if Trump actually saw what was happening at NGIO, he would at least be interested in including them in Operation Warp Speed as even a backup-plan. I just think that no one knows about GNBT/NGIO at those levels. Perhaps a Trump/GNBT supporter could alert him to our shiny object that is about to be the sexy new thing...I hear he sometimes checks Twitter...
Let's talk about how this could happen in the case of the small plasma company in the article...
If the small plasma company had FDA clearance already, and was in production on a contract basis elsewhere, this would be a very realistic award as the company would have had a commercialized product and simply just need to scale its facilities to meet demand. It is also possible that the address on file with BARDA and FDA for the company is the person's home address and that company maintains the design history file either by an outside consultant or electronically themselves ensuring that the company is compliant to the quality standard set forth by the FDA for reporting and other responsibilities. While this is not super common, it does happen especially when the contract mfg is abroad. (Please note: I am completely naive when it comes to specific regulations on blood plasma products)
Given the amount of funding is only $750,000 it sounds like the small company is getting the funding to perform a "proof of concept" for commercialization, and will then gain some additional funds in a series that may add up to $63MM once they are to scale. I am also dubious though about the $63MM being earmarked and the alleged close relationship between the company owner and Santorum as well as other key figures in the process. One would think they would excuse themselves from the process after sharing their views/potential ownership conflict and let others vet the company based upon merit. I think the article does attempt to highlight this that the Dr. Kadlec character does not have direct affect on the process, but it should explain the situation better so that it is clearer.
Getting back to NGIO, I believe that we may be pleasantly surprised by the funding matrix that is being setup, and may offer the most flexibility in scientific pursuits and commercialization. If NGIO is able to not have golden handcuffs affixed in the immediate future. Would be a lovely problem to have though sometime in the short term, or medium term future and would certainly help drive interest to the NGIO IPO
If I were involved with NGIO directly, I would recommend they sign as many OUS deals as quickly as possible so that perhaps those deals could be "grandfathered" for a specific term prior to BARDA funding which may come with tentacles and limitations about where and when the fully developed vaccine can be made available.
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