Gilead early on in the pandemic at the beginning of the break-out in China went to China to start trials for Remdesivir. I believe they did a few trials there. We talked about it and had a possible partner but nothing came of it. Maybe someone knows some answers to my next few questions? Was Gilead trial protocol FDA pre-approved for the data in China and have use for the EUA here in the US? Is any trial data from other countries exclusively somehow usable in the USA for FDA approval or do all trial information have to be partially performed in the USA?
What I am wondering is if we conduct trials in other countries and seek approval in those countries is any of that data usable here in the USA? Is there a way to get trial protocol first approved by our FDA and conduct some of the trial in the USA and the rest in other countries? Or maybe trial protocol from another country’s FDA or equivalent be used for a EUA here in the USA? So many questions...
I have always thought the piecemeal of multiple drugs used for standard of care that Dr. Patterson mentioned early on would diminish our chances at great results. Nader mentioned that yesterday when he said that the FDA has done a great job with SOC. I can’t help but wonder... Had we had the very first trial results of any drug. Would we have 60-80% mortality on our own without any other drug? Maybe some countries like the Philippines who suggested to trial Leronlimab against the standard of care will show the use of Leronlimab on its own merit with no other drugs.
The lure of better or quicker attainable results are what CYDY seeks with timely fair treatment we are not receiving here from our FDA. To be able to have results that are possible sales of Leronlimab for a non-revenue company is also desirable. Our deminished return on doses of Leronlimab will probably be some what reduced but it is revenue and we should be thankful as investors that trials won’t be diluting the stock at all or as much any longer. If foreign trials could actually fund our other indications for HIV and Cancer then we should be jumping for joy. Let’s hope this is the correct path! We may not have quick action from our FDA but I don’t want to hear the old saying down the road... “if only we just waited.” Or “ patience is a virtue.” Let hope our foreign trials helps the world and the USA still.
On a personal note*** since no more trials here in the USA will be commencing. I hope the possibility of EIND for Leronlimab here in the USA is approved for those who know about Leronlimab and may need it.
What I am wondering is if we conduct trials in other countries and seek approval in those countries is any of that data usable here in the USA? Is there a way to get trial protocol first approved by our FDA and conduct some of the trial in the USA and the rest in other countries? Or maybe trial protocol from another country’s FDA or equivalent be used for a EUA here in the USA? So many questions...
I have always thought the piecemeal of multiple drugs used for standard of care that Dr. Patterson mentioned early on would diminish our chances at great results. Nader mentioned that yesterday when he said that the FDA has done a great job with SOC. I can’t help but wonder... Had we had the very first trial results of any drug. Would we have 60-80% mortality on our own without any other drug? Maybe some countries like the Philippines who suggested to trial Leronlimab against the standard of care will show the use of Leronlimab on its own merit with no other drugs.
The lure of better or quicker attainable results are what CYDY seeks with timely fair treatment we are not receiving here from our FDA. To be able to have results that are possible sales of Leronlimab for a non-revenue company is also desirable. Our deminished return on doses of Leronlimab will probably be some what reduced but it is revenue and we should be thankful as investors that trials won’t be diluting the stock at all or as much any longer. If foreign trials could actually fund our other indications for HIV and Cancer then we should be jumping for joy. Let’s hope this is the correct path! We may not have quick action from our FDA but I don’t want to hear the old saying down the road... “if only we just waited.” Or “ patience is a virtue.” Let hope our foreign trials helps the world and the USA still.
On a personal note*** since no more trials here in the USA will be commencing. I hope the possibility of EIND for Leronlimab here in the USA is approved for those who know about Leronlimab and may need it.
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