Relief Therapeutics Holding AG (RLFTF)

[Uncle Gee Gee]

I am going to post this on Yhoo. I've said a lot of this already on this board, but in case you missed it...

My thoughts on Approval Timeline…

There’s a LOT of guessing of when people “think” or “believe” an announcement will come, and whether that will be EUA or full FDA approval. Let’s take a more structured approach to analyze the expected timeline through Javitt’s comments during his most-recent presentation last Thursday, Oct 15th in the Solebury Trout Webcast. Javitt said…

“The Covid study is moving forward with incredible velocity. We expect to read-out the Phase 3 trial by the end of the year. But, ah, 2 weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And ah, they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see. Or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to stopping the trial.”

Now… let’s unpack this and take a closer look at his words:

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First, he said the DSMB will meet “2 weeks from now”.

Notice he did NOT say “in EXACLY 2 weeks from now”. I was not able to find a date for the DSMB meeting, so given he said those words on Thursday, we can assume the DSMB should be meeting somewhere within the last several days of October or the first several days of November.

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Then he said… “And ah, they're going to review the first 102 patients in the trial.”

Now, I don’t know how these meetings work, so I have questions regarding the decision-making process…

Will all the decision makers be familiar with the data by the time they get to the meeting, and therefore, they are prepared to discuss the first 102 patients right then and make a decision?
-OR-
Is someone else preparing the data and presenting it at the meeting for the decision makers to have a “first-look” at the data, and therefore more time will be needed to discuss and make a decision?

Also, is the meeting public, so we can hear the determination first-hand? Or is the meeting private and will need to wait for an official announcement to be prepared?

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Then he said… “They have the potential to see both futility, which we hope they won't see. Or perhaps they will see overwhelming evidence of efficacy.”

The fact that Javitt only gave 2 outcomes (and excluded a potential 3rd option of “needing more data”), and the fact that he described option 2 as “OVERWHELMING evidence of efficacy”, I think it is safe to assume he is more-than-confident that the DSMB will see overwhelming evidence of efficacy in the data.

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Then he said… “Either, which would lead to stopping the trial.”

This statement tells me he is fully expecting the trial to be stopped, based on overwhelming evidence of efficacy. It would be unethical to continue the trials until the end of the year and continue giving half the patients a placebo, leaving them with a much greater chance to die… but more importantly, it would be unethical to continue the trials, leaving all the other critical patients across the United States from now until the end of the year to die.

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So here’s my assessment:

I think the DSMB is going to give EUA approval first… this will expand the drug to all critical patients in the USA. Then shortly after, it becomes SOC (standard of care). During that time, the FDA has the opportunity to observe results before giving full FDA approval by year end or January.

So… a decision to stop the trial is coming, along with EUA. It could come as early as next week, or if the DSMB meeting process requires review, then discussion, then decision-making, then official announcement… it could be as late as mid-November.

My personal opinion is if EUA doesn’t happen next week, then it will happen by Nov 5th at the latest.

We are so close! Have patience my investing brothers and sisters.