I feel this separation move will improve the results in both groups. The issue was people over 65 with immune responses not quite as good as people under 65. For those over 65 receiving a quick IV dose of Leronlimab and then two additional doses is an expected improvement for a weakened immune system that just happens from aging. Separating those with weakened immune responses and adding more treatment doses just makes sense for an immune modulating drug.
Continuing the under 65 with just two doses as the CD-12 trial used and showed some significant results. This change should allow great results in both groups if giving more Leronlimab to over 65 proves to be helpful.
Who knows if we would be waiting for any EUA right now if Dr. Jay Larilazari had been listened to by the FDA when he begged for up to 4 doses for patients. Allowing this discretion to the treating doctors based on results of lab testing and bio markers only makes sense.
Then you have Remdesivir getting 4 IV doses as their primary therapy which was no problems for Gilead to receive more dosing treatments because ??? Why???.
Maybe Gilead has more influence and Cytodyn begs and receives a “NO”. Doesn’t seem fair to me. Let’s see if they allow us the two separate trials to be fair to us now. I believe it’s a great separation allowing more Leronlimab for those over 65 that just may need more because of a weakened immune system based on age.
I have to wonder about “what if” Dr. Larilazari was listened to and we received 4 dose treatments just like Gilead. Would we be celebrating a full approval? Would 4 doses have been the doses that would of shown much better results for those who didn’t respond to only two doses. We can only speculate but what if 4 doses kept an additional 25% or more from dying? We can only speculate now but a full BLA could allow doctors that chance to use Leronlimab in more doses if they feel by lab results and bio markers for precision medicine to work as they see improvement. As long as it would benefit the patient then why not allow some flexibility in doses?
It will be interesting to see if Dr. Larilazari could of been right all along. Chances are we will never know because if approved with an BLA and freedom to use as doctors prescribe. Would we even track how many doses are used. I would hope so. But reality is... probably not.
Continuing the under 65 with just two doses as the CD-12 trial used and showed some significant results. This change should allow great results in both groups if giving more Leronlimab to over 65 proves to be helpful.
Who knows if we would be waiting for any EUA right now if Dr. Jay Larilazari had been listened to by the FDA when he begged for up to 4 doses for patients. Allowing this discretion to the treating doctors based on results of lab testing and bio markers only makes sense.
Then you have Remdesivir getting 4 IV doses as their primary therapy which was no problems for Gilead to receive more dosing treatments because ??? Why???.
Maybe Gilead has more influence and Cytodyn begs and receives a “NO”. Doesn’t seem fair to me. Let’s see if they allow us the two separate trials to be fair to us now. I believe it’s a great separation allowing more Leronlimab for those over 65 that just may need more because of a weakened immune system based on age.
I have to wonder about “what if” Dr. Larilazari was listened to and we received 4 dose treatments just like Gilead. Would we be celebrating a full approval? Would 4 doses have been the doses that would of shown much better results for those who didn’t respond to only two doses. We can only speculate but what if 4 doses kept an additional 25% or more from dying? We can only speculate now but a full BLA could allow doctors that chance to use Leronlimab in more doses if they feel by lab results and bio markers for precision medicine to work as they see improvement. As long as it would benefit the patient then why not allow some flexibility in doses?
It will be interesting to see if Dr. Larilazari could of been right all along. Chances are we will never know because if approved with an BLA and freedom to use as doctors prescribe. Would we even track how many doses are used. I would hope so. But reality is... probably not.
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