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Posted On: 10/17/2021 7:10:52 PM
Post# of 148884
Re: jojopaint57 #107975
Part of your quote jojhopaint;
"Management has not met the challenges of providing complete and air tight submissions."
Management has made some mistakes and I grant you that but the biggest fumble was by the US fda, our DSMB and our previous CRO and we have yet to find out the final outcomes of those. I remember very clearly that the US fda would only allow 2 doses and not allow 4 doses SubQ for CD 10 or 12, just ask Dr. Laz and that was to keep Leronlimab on the shelf at that period of time while they shoved through vaccines instead of therapeutics with life saving abilities like Leronlimab. Don't forget the delays that the US fda placed upon Leronlimab for our HIV trials switching back and forth on our combo & monotherapy trials and a lot more asking of information every time we sent data back to them only to make Cytodyn combine the trial information data over and over, then the dosage of 350 then 525 then 700 data requests. Oh I digress. If we were Merck or Gilead or even Phizer, this would have never happened and you know what else? If Cytodyn had partnered with any one of the above with our trials, they would have been EUA'd or approved on the first go around - GLTU
HCIT
"Management has not met the challenges of providing complete and air tight submissions."
Management has made some mistakes and I grant you that but the biggest fumble was by the US fda, our DSMB and our previous CRO and we have yet to find out the final outcomes of those. I remember very clearly that the US fda would only allow 2 doses and not allow 4 doses SubQ for CD 10 or 12, just ask Dr. Laz and that was to keep Leronlimab on the shelf at that period of time while they shoved through vaccines instead of therapeutics with life saving abilities like Leronlimab. Don't forget the delays that the US fda placed upon Leronlimab for our HIV trials switching back and forth on our combo & monotherapy trials and a lot more asking of information every time we sent data back to them only to make Cytodyn combine the trial information data over and over, then the dosage of 350 then 525 then 700 data requests. Oh I digress. If we were Merck or Gilead or even Phizer, this would have never happened and you know what else? If Cytodyn had partnered with any one of the above with our trials, they would have been EUA'd or approved on the first go around - GLTU
HCIT
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