Good to go:
drD on YMB confirmed my original statement that LL scheduled administration was continued on the mTNBC patients even after the trial was closed.
gestalt2:
I think FDA makes it easy on those companies they have dealt with, who they are familiar with, and certainly if a a whole lot of grease is lavishly heaped over all the sticking points. On the other hand, for those companies requiring FDA educating, unless every "t" is crossed and every "i" dotted, they can make you write the same encyclopedia till your hands bleed. Indications seem to have no bearing.
sean007:
Provided one uses actual facts, actual statements, common sense, piecing together the puzzle pieces remains healthy and may produce some possibly realistic scenarios.
AeroDude:
The above may also be stated here. And it is precisely that, the drug working so exquisitely well, devoid of side effects while enhancing our own innate to conquer disease, which validates our bullishness.
sean007:
from 12/14/21 cc:
so, we're looking for partner for Phase 3. Database lock should have been done in January or so... NASH 700 results slated for June 25. How could that Phase 2 trial be closing mid-July? Maybe they want to include the aggregated safety data since Amarex was CRO?
Figgs:
Amarex must take place, it's outcome needs to be realized, but I still see it as sort of a detour, off the beaten bath. But it must come to resolution, and I only see one, which eliminates Amarex from this arena. SK as well as CR said the problem will be overcome by mid-late June and the announcement of aggregated safety data will be made. The IP on LL & patent are no longer at risk. Justice will come to pass. Life goes on.
Quote:These women we know were still alive last year due to their taking leronlimab. Unfortunately, you can’t assume anything more than that . You say you believe they continued to take it because it would be common sense. While you’re right that any logical company would of course continue their patients on the drug to see just how long they could keep on surviving, you’re forgetting one important thing: this is Cytodyn …
drD on YMB confirmed my original statement that LL scheduled administration was continued on the mTNBC patients even after the trial was closed.
gestalt2:
Quote:This is what boils my blood, why does the FDA care about what is the best drug? Why not just take any and all drugs serious if they show good trial results for a very deadly disease? It is not a race for the best drug, it is a race to treat a disease with all possible drugs. BTD exists because of the FDA’s slow and expensive process. They created it because it is so difficult to get a drug through the normal process. What is wrong with having 2 treatments for mTNBC?
I think FDA makes it easy on those companies they have dealt with, who they are familiar with, and certainly if a a whole lot of grease is lavishly heaped over all the sticking points. On the other hand, for those companies requiring FDA educating, unless every "t" is crossed and every "i" dotted, they can make you write the same encyclopedia till your hands bleed. Indications seem to have no bearing.
sean007:
Quote:"And doesn't appear"...is both slanderous and a libelous statement...when one DOESN"T know for a FACT...that what they are saying is absolutely beyond reproach and provable..and NONE of us do. The curtain has not been drawn back...and this isn't OZ.
Bonne Journee.
Provided one uses actual facts, actual statements, common sense, piecing together the puzzle pieces remains healthy and may produce some possibly realistic scenarios.
AeroDude:
Quote:Craig- nobody knows if there is a buyout/partnership in the works or not, nobody does. As far as the SP, Dr Lalezari summed up the cause in his presentation. FDA corruption, Faulk, shorts and all the blah blah is cheap talk. The good and the most important thing is: the drug works, and that is the reason why you, I and everyone here, is still here.
Let’s hope they make it to the finish line.
The above may also be stated here. And it is precisely that, the drug working so exquisitely well, devoid of side effects while enhancing our own innate to conquer disease, which validates our bullishness.
sean007:
Quote:Ganesha... I believe you are correct...further digging suggests that the estimated Study Completion date is July 22-2022. That being said.. Amarex is the provided collaborator...SO not clear... if any of the information at this juncture is fact-based...and subject to further updates. Phase 2 and 60 participants.
from 12/14/21 cc:
Quote:24:17 Recknor: We are working on database lock right now. Shortly thereafter, we are looking at before Christmas vacation, being able to produce a topline report. And this gives us the ability to look at what's going on with the 700mg dose, which I'm very excited to see, and looking at the 350mg dose, as compared to the placebo, in the double blind portion Part 1, so we are really excited.
24:47 Nader: Yeah, and some people are saying in other NASH trials, they do a 1,000 patients, so we probably need a partnership, with 1000, 2000 or 10,000 patients, if you hit your primary & secondary endpoint, that's a huge deal. We don't know what we have, cause we haven't unblinded it yet, but we are really waiting to see how that comes out.
so, we're looking for partner for Phase 3. Database lock should have been done in January or so... NASH 700 results slated for June 25. How could that Phase 2 trial be closing mid-July? Maybe they want to include the aggregated safety data since Amarex was CRO?
Figgs:
Quote:Like to see everything on a positive note just to keep the share price up so it's easier to raise money; you want trials to happen, keep the share price up.
Then there's Amarex. All roads lead to and through Amarex. There is a possibility that everything could be on hold because of Amarex. And I mean everything HIV, mTNBC, NASH, LH, CD12 etc, safety, all Amarex. So before we make any assumptions about anything, I think we need to find out just what Amarex did or didn't do.
Amarex must take place, it's outcome needs to be realized, but I still see it as sort of a detour, off the beaten bath. But it must come to resolution, and I only see one, which eliminates Amarex from this arena. SK as well as CR said the problem will be overcome by mid-late June and the announcement of aggregated safety data will be made. The IP on LL & patent are no longer at risk. Justice will come to pass. Life goes on.
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