Replies to post #22376 on Relief Therapeutics Holding AG (RLFTF)

[nelskof]

From Dr Javitt's comments about the role of the DMC they can only make 4 decisions.

1. Stop the trial due to safety concerns
2. Stop the trial due to a lack of efficacy
3. Continue the trial because they believe it can meet it's end points
4. End the trial because the evidence is so overwhelming it's unethical to continue placebo

Can't we assume it's #3 just based off Dr Javitt's comments that the trial would be unblinded in about a month? The other options are to end the trial and we know that didn't happen.

What info are you hoping to glean from the interim update? Serious question because biopharma's are not an ordinary investment for me. The PR after the DMC looked at 30 patients only said #3 from above.

[aGuyUS]

ClinicalTrials.gov Identifier: NCT04311697
AKA "Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)"
Recruitment Status : Recruiting
First Posted : March 17, 2020
[color=red]Last Update Posted : August 31, 2020[/color]

THE DMC I believe met may have met and made a determination as the Study was Updated August 27

The Link Below Shows a side by side comparison of July 27 module V.12 and the August 27 Module v 13

https://clinicaltrials.gov/ct2/history/NCT04311697?B=13&A=14&C=Side-by-Side#StudyPageTop


Green highlights in the comparison are Additions
Red highlights in the comparison are deletions

All deletions are on the Left Document and All Additions are on the Right document. This suggests to me they met in August as they were supposed to and made a decision to Continue the trial without changing the Trial study from the July 27 Module

[NickHous]

Kiwi, to me it would appear if not for Dr Lavin on the Neurorx team, they would not have bothered with the EUA submission. Dr Lavin's credentials are top-notch and it would seem on the surface that Neurorx and Dr Javitt/Dr Lavin have confidence touting the low P values in their submission. I believe they are <.01 and <.001. Of course the interim data should also be available by now. I would think this would be available to the FDA in their EUA determination by this point. I'm sure Dr Lavin has all sorts of biostatistics available by now to further substantiate the effectiveness of RLF100 including interim analysis details. All that being said, we are still in that "waiting for confirmation/news" period and have to rely on any kind of "reading into" any tidbits from the Dr Javitt (Sachs conference video and upcoming wednesday Dr You interview). Looking forward to the wednesday Dr Yo and Dr Javitt interview. To me, Dr Javitt's enthusiasm in these youtube events is a tell-tale sign, and he seems every time he speaks he hints/discloses upcoming events or details into the trials/partnerships/manufacturing/etc. Have a great day!

[aGuyUS]

Kiwi,

The DMC apparently met because the Clinical trial was updated. The update wouldn't have been done unless they had met . It was submitted for changes on August 27th. We know that because their is a new version of it on the clinical trial site.

Please see and review the side by side comparative of v. 12 and v. 13
https://clinicaltrials.gov/ct2/history/NCT04311697?A=13&B=14&C=Side-by-Side#StudyPageTop

August 27 Version lists changes to
1 Last Update Submitted: August 27, 2020
2. LAst Updated POSTED: August 31, 2020
3. Secondary Measures Adds on Item 5. Days free of Respiratory Failure
Days free of Respiratory Failure
[Time Frame: 14 days ]

These were the only changes the DMC made to the review apparently.


Additionally as of about yesterday or the day before 9/23/2020 we now know the Trial is close for enrollment. Clinical site Isn't Updated to that effect yet because apparently changes are recorded on or about the 27th to 30th of the month for the past three months on the Clinical site.

but the enroller site says in GREEN:

RECRUITMENT STATUS: CLOSED Last updated on September 2020
Here

https://www.centerwatch.com/clinical-trials/listings/245622/intravenous-aviptadil-for-critical-covid-19-with-respiratory-failure/?section=elg

It is apparent that the company has made a decision not to release press on either of these two subjects...and because it is proprietary information, it is their choice to make


Hope this helps