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Posted On: 02/11/2022 12:49:18 PM
Post# of 148894
Re: longhauler trial
On October 26, 2021, I received an email from the trial recruiter from CARE (Center for Advanced Research & Education) that the FDA had approved the longhauler protocol and that the trial would be starting soon. Then in November, I received another message that it wouldn't be starting until January/February 2022. I haven’t received any further updates on it since November.
I’m not sure if the delay in the start of the longhauler trial is protocol related or more of a change in strategy, but I can think of several potential reasons for it:
In discovering more about Leronlimab, Cydy decided to tweak the protocol and had to go back to the FDA for re-approval.
The protocol is being expanded to include other inflammatory conditions, such as chronic fatigue, Epstein Barr, etc.
A partner is waiting in the wings that wants a piece of longhaulers, and with this partner the trial can be larger and enroll faster.
They are waiting for the Brazil data for an EUA or similar for critical covid, and if Albert Einstein did a good job, they might do the longhauler trial there instead.
Maybe Brazil has given them feedback that success with critical will open up the use of Leronlimab for all Covid phases, including longhaulers.
They are waiting for a catalyst on another condition, such as NASH results, or mtnbc breakthrough status, to raise the share price, so that they can finance or raise working capital to fund the trial.
There has been a change in strategy, perhaps the HIV BLA is closest to the finish line and they decided to complete that first, and then use Leronlimab off label for these other conditions.
Longhaulers has been back-burnered as it’s “all hands on deck” dealing with the data dump for HIV, mtnbc breakthrough expanded survival data, 700mg nash data, etc.
Longhaulers has been back burnered because a potential partnership on another indication, like cancer or nash, will provide the much needed funding for the trial.
On October 26, 2021, I received an email from the trial recruiter from CARE (Center for Advanced Research & Education) that the FDA had approved the longhauler protocol and that the trial would be starting soon. Then in November, I received another message that it wouldn't be starting until January/February 2022. I haven’t received any further updates on it since November.
I’m not sure if the delay in the start of the longhauler trial is protocol related or more of a change in strategy, but I can think of several potential reasons for it:
In discovering more about Leronlimab, Cydy decided to tweak the protocol and had to go back to the FDA for re-approval.
The protocol is being expanded to include other inflammatory conditions, such as chronic fatigue, Epstein Barr, etc.
A partner is waiting in the wings that wants a piece of longhaulers, and with this partner the trial can be larger and enroll faster.
They are waiting for the Brazil data for an EUA or similar for critical covid, and if Albert Einstein did a good job, they might do the longhauler trial there instead.
Maybe Brazil has given them feedback that success with critical will open up the use of Leronlimab for all Covid phases, including longhaulers.
They are waiting for a catalyst on another condition, such as NASH results, or mtnbc breakthrough status, to raise the share price, so that they can finance or raise working capital to fund the trial.
There has been a change in strategy, perhaps the HIV BLA is closest to the finish line and they decided to complete that first, and then use Leronlimab off label for these other conditions.
Longhaulers has been back-burnered as it’s “all hands on deck” dealing with the data dump for HIV, mtnbc breakthrough expanded survival data, 700mg nash data, etc.
Longhaulers has been back burnered because a potential partnership on another indication, like cancer or nash, will provide the much needed funding for the trial.
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