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Monroe1

09/22/20 9:01 PM

#118407 RE: misiu143 #118397

How about a side by side long hauler study with Remesevir, Coval Plasma, and the other contenders and a placebo. I would opt for that but only that. Fair is fair but not the FDA. They don't play that way, they have other bases to cover.
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Learning53

09/22/20 11:07 PM

#118459 RE: misiu143 #118397

misiu143,

I appreciate your post. Yes...Guilty! I have been pushing for the long-hauler trial for a few reasons:

1. It appears Leronlimab (as per the M-M) starts positively making changes by the third day. While changes do not = instant cure, it does mean the various indicators (CD-4,CD-8, IL-6, etc.) are coming back into balance. ...And the cytokine storm begins to subside.

2. While everyone is chasing the vaccine/immediate treatment "golden fleece," Leronlimab would be virtually alone in going after the "long-hauler" market.

3. It has been hard getting "traction" in the (covid treatment/cure) crowded field of applicants. LL gets lost in the shuffle. Meanwhile, there are already frustrated groups of organized "long-haulers" that would provide potential motivated pressure for approval.

4. This would not be a Looooooong trial. It either works (in 3, 7, 14, or 28 days ?) or doesn't. Plus, it would be easier to populate such a trial as there are many reaching out for relief.

5. This is a very significant market. I wonder if there is any count as to what percentage of the "recovered" have varying degrees of the "long-hauler" syndrome? I've seen estimates ranging from one third to seven eighth's of "recovered" exhibit varying degrees of "long-hauler" syndrome. That's talking a market of millions in the USA alone...and elsewhere?

6. Many "long-haulers" no longer have any remnants of Covid19, in fact some never seemed to manifest the disease. For that reason many if not all of their expenses must be covered by insurance or are totally "out-of-pocket." These people (and families) are desperate.


But...Rockleo's post really "rocked my boat. " I do not wish to jeopardize the success of Leronlimab. This is why, Misiu143, I really appreciate your post. It seems imperative a "long-hauler" trial must include entry parameters noting the previous health of the patients. Rockleo's point is well taken, many of these people may have profound "pre-existing conditions" and LL is not "Jesus curing the afflicted." LL may be able to help with the immunological aftermath of Covid19 but will not help the lame to walk or the blind to see. For that reason - applicant screening to rule out confounding pre-existing conditions would be a key for acceptance.

So ...THANK YOU.. now for the Rock...

Rockleo - what do you think about Misiu143's suggestion?