DD and Thoughts on today from Investor Hub
DD Post & Some Thoughts on Today:
Looking at this link to the Clinical Trial in question on the interview .... https://clinicaltrials.gov/ct2/show/NCT04311697
Am I missing something here? I see “estimated enrolment” to be 144 but according to the above (or below), it is tested for “safety / futility” after 30 patients are enrolled.
ALSO the June 01 PR from RLFTF said they were “aiming for 120 patients”:
“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.”
SO, to me, this sounds like NeuroRX is on-track and they have checked that “Safety” box, but he is NOT going to say “boom it’s safe” when the entire study hasn’t been completed yet and now patient 102 has come along so therefore it is NOW up to the Data & Safety Monitoring Board to report interim data — and from the looks of their website they can change things on a dime with these trials. Javitt said 28 days and I know that’s why everybody’s butt-hurt.... And he gave us the “BAD” and the “UGLY” first....but given what I am reading here from DSMB, timelines can change quickly depending on their assessment of the trial:
“The primary responsibilities of the DSMB are to 1) periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and 2) make recommendations to NIDCR concerning the continuation, modification, or termination of the trial. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.”
Now THAT is interesting, because there already exists a LOT of background data on the “test agent.”
From the Trial Notes - Background Info:
“Five phase 2 trials of aviptadil have been conducted under European regulatory authority. Numerous healthy volunteer studies have shown that i.v. infusion of Aviptadil is well tolerated with few adverse effects including alterations in blood pressure, heart rate, or ECG. In addition to published studies of human use, Aviptadil has been used on a compounded basis in certain ICUs for many years in the belief that it preserves life and restores function in pulmonary hypertension, ARDS, and Acute Lung Injury (ALI).
In this study, patients who are hospitalized for Critical COVID-19 infection with respiratory failure will be randomly allocated to Aviptadil administered by intravenous infusion in addition to maximal intensive care vs. maximal intensive care alone. Primary endpoints will be improvement in blood oxygenation and mortality.”
So, reading between the lines....
They don’t need 144 by the sounds of it. DSMB gave them the OK after 102. Also, Dr. Javitt was very clear in saying that this is NeuroRX’s trial on a medication that has been used for a long time... Later he mentions Relief Therapeutics, etc, but I frankly don’t see any issue with him sharing that timeline & the fact that they have 102 participants.... NeuroRX is privately held, so he has not said anything here that puts RLFTF in violation with Securities Laws. Shareholders dumped when he said things like “we have not applied for expanded applications,” bla bla.... because Traders were thinking “Ha he is gonna say this shit works on influenza, makes my dick hard, and ALSO cures covid, study done, ready to roll.” YEAH RIGHT. He clearly BELIEVES in other applications but STEP ONE here after Expanded Access is to get the EUA ..... Dr. Javitt is not going to push a bunch of extras in NOW when there is dire need to get this stuff to patients through Pharmacies! Second half of the video is awesome because it’s like he KNOWS there is efficacy here, and he has a rolling list of publications (top 1% in the world), so he’s got
But anyway, that’s my .02. Also I would advise watching this page here, since it was last updated end of August, it would make sense to have an update here any time? Amid the “covid frenzy,” it would not surprise me to see an interim update “soon” on here, after a nod from DSMB:
To me, the News today coupled with this page = money in the bank.
“Approval of a Drug can only be achieved if the drug is shown to be safe and effective....”
“The standard for Emergency Use is different .... it has to be SAFE and MAY be effective.” ... “We clearly have evidence this drug may be effective.”
Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
Intervention Model Description:
Multicenter trial, initially conducted at a single center with a safety/futility assessment following enrollment of 30 patients
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Randomized, placebo-controlled trial with identical drug and placebo infusion bags
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
Actual Study Start Date :
May 15, 2020
Estimated Primary Completion Date :
Estimated Study Completion Date :
TLDR(?) - Too Lazy Didn’t Read —
DSMB likely assessed the trial’s preliminary data ALREADY and said 102 patients was sufficient. June PR said the study aimed for 120. Clinical Trial NCT04311697 said “estimated 144 patients.” [U]Dr. Javitt did NOT incriminate himself or say anything damning here in speaking about his PRIVATE company’s Clinical Trial. 28 days is an “earmark” that can change swiftly —both North or South, let’s keep in mind — based on such things as the background of testing agent, population in study, etc. IMO speaking of violation of Securities Laws is egregious here, given that NeuroRX is private & is advancing RLF-100 in a new application... original aim was 120 patients. Let’s not make a mountain out of a mole hill.
Thanks for reading all the verbiage ;) ..... I always keep a pot o’ gold kickin’ around for the monkey market bedshitting, so let’s see what we get tomorrow ;) .... imo :)