(Total Views: 482)
Posted On: 01/05/2023 1:59:16 PM
Post# of 154804
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I still regret that we are not pursuing LC. From the anecdotal reports I heard, many in the LC trial were helped by Leronlimab. Sure would like to know why we dropped that.)
I think we are not running clinicals, for Long COVID, for the same reasons that a lot of other's aren't. Long COVID appears to be an ambiguous subject to pin down under a set criteria. It is such a personal thing, based on:
Medical conditions at the time the subjects were infected.
Existing immune related issues.
The degree of severity of symptoms.
The variety of symptoms.
What biomarkers can give positive indications of benefit.
Whether the symptoms are stemming from either immune conditions or viral reservoirs.
Either describing or proving the mechanism of action, when the symptoms and patients are so varied in magnitude (the FDA has shown they consider Leronlimab as an immune system suppressor. This would be a bad clinical to use, to convince them otherwise).
I can understand the difficulties in writing a thorough protocol and then proving that a drug was responsible for effects on symptoms. The FDA seems to have little desire to sort out minutiae..They want the all mighty numbers to show efficacy. How do you do that, when what your working with, is so ambiguous?
Personally, based on our history (with everything), I see very little chance of the FDA considering such a trial from a small company, with an unapproved drug. I think our management has made the right call, on this.
Read More: https://investorshangout.com/post/newpost/605...z7pXtpFmA7
I still regret that we are not pursuing LC. From the anecdotal reports I heard, many in the LC trial were helped by Leronlimab. Sure would like to know why we dropped that.) I think we are not running clinicals, for Long COVID, for the same reasons that a lot of other's aren't. Long COVID appears to be an ambiguous subject to pin down under a set criteria. It is such a personal thing, based on:
Medical conditions at the time the subjects were infected.
Existing immune related issues.
The degree of severity of symptoms.
The variety of symptoms.
What biomarkers can give positive indications of benefit.
Whether the symptoms are stemming from either immune conditions or viral reservoirs.
Either describing or proving the mechanism of action, when the symptoms and patients are so varied in magnitude (the FDA has shown they consider Leronlimab as an immune system suppressor. This would be a bad clinical to use, to convince them otherwise).
I can understand the difficulties in writing a thorough protocol and then proving that a drug was responsible for effects on symptoms. The FDA seems to have little desire to sort out minutiae..They want the all mighty numbers to show efficacy. How do you do that, when what your working with, is so ambiguous?
Personally, based on our history (with everything), I see very little chance of the FDA considering such a trial from a small company, with an unapproved drug. I think our management has made the right call, on this.
Read More: https://investorshangout.com/post/newpost/605...z7pXtpFmA7
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