So my thoughts around the info we have so far on t
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Posted On: 02/04/2021 11:46:26 AM
So my thoughts around the info we have so far on the vaccine are starting to coalesce a bit. I'll throw them out for you guys to punch holes in and to see how they match up w tomorrow's update:
1) The mouse immunogenicity trial nugget seemed to be received as a negative yesterday. After thinking about it, I think it's a positive for a couple of reasons...
a) The FDA is fully engaged and advising Joe and Team. A good and substantial thing.
b) If the mouse testing is successful, I would think this would be very helpful in designing a scientifically strong clinical testing plan and would probably streamline the testing timeline.
2) The production of vaccine has been initiated, and the fill/finish is contracted for the vaccine for trials. So when the mouse data comes in, the trial design will be finalized, and trials should begin relatively promptly.
3) I believe, because of our safety profile, we will be holding a combined Ph I/Ph II trial. I can't find my source for that (other than my memory - a comment from Joe or Dr EvH on a call, I think), but maybe someone remembers where that came from. So that suggests a condensed time frame. I believe it was suggested possibly in the 2 month time frame.
4) Again, due to the type of vaccine and the safety history, we are looking at a smaller number of participants than some of the other trials (PFE, MRNA). Again, probably a faster/cheaper trial with less data to juggle throughout and to analyze after testing (but obviously enough to know if endpoints are met!).
5) The idea of "licensing therapeutic monoclonal antibodies for the treatment of COVID-19 disease" is certainly an exciting avenue that adds to the potential for our science.
6) Almost 4,000 people died in the US yesterday from CV-19. Only ~2% of the population has been vaccinated, and the durability/LT safety (and effectiveness?) of the vaccines given is still in question. There is clearly a need for additional vaccines.
7) Can you imagine if we have Ph I/II success how much attention will be brought our way? Especially when Joe says, well, this is a simple production process. We can make you a billion doses in a month if there's fill/finish capacity for it! The Ph III trials will have the world's eyes for sure.
All in all, I think the long lapse in our visibility to progress and the rocky road we have traveled have taken their toll on all of us. But Joe and Team have continued to execute behind the scenes, from moving forward w the NGIO IPO to vaccine work to keeping GNBT teed up and ready when funding hits.
We are in a fantastic spot right now, and I believe we will hear some great things tomorrow. Maybe it takes until the IPO or Ph I/II testing results for the world to notice us. But if we continue this slow climb up, the ride is going to get better every day!
1) The mouse immunogenicity trial nugget seemed to be received as a negative yesterday. After thinking about it, I think it's a positive for a couple of reasons...
a) The FDA is fully engaged and advising Joe and Team. A good and substantial thing.
b) If the mouse testing is successful, I would think this would be very helpful in designing a scientifically strong clinical testing plan and would probably streamline the testing timeline.
2) The production of vaccine has been initiated, and the fill/finish is contracted for the vaccine for trials. So when the mouse data comes in, the trial design will be finalized, and trials should begin relatively promptly.
3) I believe, because of our safety profile, we will be holding a combined Ph I/Ph II trial. I can't find my source for that (other than my memory - a comment from Joe or Dr EvH on a call, I think), but maybe someone remembers where that came from. So that suggests a condensed time frame. I believe it was suggested possibly in the 2 month time frame.
4) Again, due to the type of vaccine and the safety history, we are looking at a smaller number of participants than some of the other trials (PFE, MRNA). Again, probably a faster/cheaper trial with less data to juggle throughout and to analyze after testing (but obviously enough to know if endpoints are met!).
5) The idea of "licensing therapeutic monoclonal antibodies for the treatment of COVID-19 disease" is certainly an exciting avenue that adds to the potential for our science.
6) Almost 4,000 people died in the US yesterday from CV-19. Only ~2% of the population has been vaccinated, and the durability/LT safety (and effectiveness?) of the vaccines given is still in question. There is clearly a need for additional vaccines.
7) Can you imagine if we have Ph I/II success how much attention will be brought our way? Especially when Joe says, well, this is a simple production process. We can make you a billion doses in a month if there's fill/finish capacity for it! The Ph III trials will have the world's eyes for sure.
All in all, I think the long lapse in our visibility to progress and the rocky road we have traveled have taken their toll on all of us. But Joe and Team have continued to execute behind the scenes, from moving forward w the NGIO IPO to vaccine work to keeping GNBT teed up and ready when funding hits.
We are in a fantastic spot right now, and I believe we will hear some great things tomorrow. Maybe it takes until the IPO or Ph I/II testing results for the world to notice us. But if we continue this slow climb up, the ride is going to get better every day!
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