(Total Views: 737)
Posted On: 12/27/2020 12:11:14 PM
Post# of 148903
Re: craigakess #69830
There is something important happening Monday. It would be solid if Duterte signs the Philippines budget. (If he approves.) I feel that is what we need to happen in order to achieve our early EUA with the Philippines.
The talk of having a EUA in your own country first isn’t how I read the amendments they put into their process for early EUA possibilities. It gives a... “me too” clause to previously approved drugs that are already approved in their own countries to be approved in the Philippines. Only Covid related I’m sure.
I believe the real bonus that it was amended was to allow partial trial efficacy at interim parts of a trial as long as 50% or more of the trial was complete and end point was attained. Therefore allowing a much earlier approval process. That would allow Leronlimab meeting those parameters for an early EUA in the Philippines. I believe if Duterte signs the budget . A purchase deal could be announced. Payment would probably be with monies after January 1st for their 2021 budget. Of coarse That is just my view but why not see the path forward in the best light? Being a fly on the wall in the Philippines or our own FDA meetings would be wonderful. But we are past the point of hope and are in “when” possibilities now. I believe we have derisked our investment and just need the process to complete. Who is first is all I wonder?
I read multiple news releases on the Philippines and their process and budget signing and this is what I gather to be true. They changed their whole FDA process to have an earlier approval for someone and that someone could very well be Leronlimab. My opinion of coarse.
So to reiterate, we have two potentially important events coming Monday. The effect on the stock price from the “Open Label Extention” and the signing possibility of the Philippines budget we should see Monday. Which could even announce a purchase deal if the budget is signed.
These two possibilities are my opinion and I don’t see why they can’t happen. All I really know is we are one day closer to helping by saving lives on a much bigger scale than just an open label extension. It’s a beautiful thing to get that extension for our 18 trial sites and EIND’s at other hospitals. But the sooner we unleash Leronlimab for EUA for unlimited locations the sooner we have a huge impact.
The talk of having a EUA in your own country first isn’t how I read the amendments they put into their process for early EUA possibilities. It gives a... “me too” clause to previously approved drugs that are already approved in their own countries to be approved in the Philippines. Only Covid related I’m sure.
I believe the real bonus that it was amended was to allow partial trial efficacy at interim parts of a trial as long as 50% or more of the trial was complete and end point was attained. Therefore allowing a much earlier approval process. That would allow Leronlimab meeting those parameters for an early EUA in the Philippines. I believe if Duterte signs the budget . A purchase deal could be announced. Payment would probably be with monies after January 1st for their 2021 budget. Of coarse That is just my view but why not see the path forward in the best light? Being a fly on the wall in the Philippines or our own FDA meetings would be wonderful. But we are past the point of hope and are in “when” possibilities now. I believe we have derisked our investment and just need the process to complete. Who is first is all I wonder?
I read multiple news releases on the Philippines and their process and budget signing and this is what I gather to be true. They changed their whole FDA process to have an earlier approval for someone and that someone could very well be Leronlimab. My opinion of coarse.
So to reiterate, we have two potentially important events coming Monday. The effect on the stock price from the “Open Label Extention” and the signing possibility of the Philippines budget we should see Monday. Which could even announce a purchase deal if the budget is signed.
These two possibilities are my opinion and I don’t see why they can’t happen. All I really know is we are one day closer to helping by saving lives on a much bigger scale than just an open label extension. It’s a beautiful thing to get that extension for our 18 trial sites and EIND’s at other hospitals. But the sooner we unleash Leronlimab for EUA for unlimited locations the sooner we have a huge impact.
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