Hi RTB, ..
For years I am reading your posts and I observed that you have a very good financial understanding and .knowledge ...since I don't , I never question or critic your posts, no matter what you posted..
But now with medicine , this is something I understand a little , so I will like to explain again what happened with leronlimab in the last few years with HIV and Covid..
--- With HIV , our combo study for MDR patients , with 350 mg had excellent results , 81% efficacy , and not one serious side effect..
FDA never question or disputed this number , even with all the hit letters on us..
We had 52 patients , but just before that ibalizumab was approved by FDA with 40 patients , so number was fine..
We finished this trial February 2018...
This is a time when FDA should give it approval , and if they wanted to see what will happen with 525 and 700 mg , studies could be done after that ..
These patients are dying since the only 2 drugs approved then and now , are...
--Maraviroc with 45% efficacy ,and Black Box warning for liver toxicity , and..
--Ibalizumab with 43% efficacy , and IV infusion every 2 weeks , and also some serious side effects..
But no , FDA said that at this time they want cydy to do trial for 6 months with 525 mg and 700 mg , 100 patients for each..
And this when all the problems started , and it is very difficult to finish this BLA properly . Surly important is also that our management is inexperience , and company without revenue..
I still hope that BLA will be done this year , properly , and FDA will need to approve this drug,
But why they made this decision from the beginning , not to approve 81% efficacy , drug without serious side effects for all this dying patients ??
I have now my theory...
February 2018 when we finished our phase 3 pivotal study with combo , Gilead was doing phase 1 for capsid inhibitor , for the same group of patients as our combo , and FDA needed to delay us..
This is my theory , and observing what is going on now , I think that I am right..
--- And now covid..we have many , over 100 patients treated with leronlimab with EINDs The most sick , when ALL other drugs failed already..
Many patients were treated by Dr Otto Yong from UCLA ..I think about 40..
He said ... ..
" leronlimab is not working well on everyone , but it is working on majority "
We met one of his grateful patient Samantha M , she is talking often on videos how leronlimab saved her life..
This statement of Dr Yang is consistent with our CD12, critical..
Leronlimab is working as no other drug in the word , when is in the system of this patients , Dr Lalezari made this exact statement in his video to NIH doctors..
But why FDA refused to let CYDY use 4 doses in severe/critical patients , drug so far without one serious side effects..
Dr Patterson observed from severe/critical Montefiore patients , that the more severe sickness the higher the Rantes , and in this severe patients Rantes still high by 14 days.
So why to give to this patients treatment only at 0 and 7 days ,
why not as cydy asked for 4 treatments , at... 0 , 7 , 14 , and 21 days at least..
At 14 days when some drug was still in the system of this critical patients , patients on the ventilators and ECMO , survival benefit ABOVE all these worthless approved drugs was 82%..
82% , as dr Lalezari said , no other drug in the world doing that..
So yes , leronlimab is the most impressive drug I ever knew..and I hope
for all of our , and our families sake it will be approve soon.
GLTU.
