Thanks man. Reaching back to old PRs ... I see we do have some boxes checked already .... really should see this stuff updated on the Trial website itself. Based on this, the language here is very important ... “within the 144 patient sample” — does not mean they NEED 144.... Originally they were looking for 120. Now I believe at patient 102 we have hit that “trigger point” where they have a suitable number of participants, as Dr. Javitt said in the interview “you’re kind of the first ones to know, we just got patient 102.... so we will have data on this in 28 days..” (BEDSHITTING in market ensues). Lol. Anyway... here are the references. I have been thinking that, sadly, because this is an “end-of-life” / “last-resort” treatment, participants have likely died as well, so they’ve perhaps had some shuffling with these numbers too?? I mean, maybe they have had folks sign up and then just die before they can even randomly assign them? That’s certainly a quantifiable consideration, I think, and something Dr. Javitt would not say on an interview.... But I do believe his words and RLFTF press have alluded to this. That is just another thing I am considering because of the uniqueness of this whole “situation”....
Ok here’s the stuff I was reading last night. I don’t think my light medicinal valium-vodka-gin-smash cocktail got me too off kilter, but please add thoughts & feedback bro! I know you have been following longer than me and are still bullish regardless of the interim action. Thanks for reading!
Re: 30 patient “safety check” “This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks.”
Prior to that —- they “aimed” for 120 patients for this trial: “
The multicenter randomized placebo-controlled trial aims to enroll 120 patients with COVID-19 who have Acute Respiratory Distress and require intensive care with mechanical ventilation. Patients will be randomized to intravenous (IV) RLF-100 plus maximal intensive care or placebo plus maximal intensive care. The primary endpoints will be mortality and index of respiratory distress. The secondary endpoint will include levels of TNFa and multi-system organ failure free days. For more details on the clinical trial, go to the government’s website: www.clinicaltrials.gov (NCT04311697).”
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