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And what is the turnaround time from FDA approval to distribution and prescribing?
I just thought the same thing. 521k people have Covid related deaths in the US. Imagine if Leronlimab had been available for the last 365 days. Around 125,040 people could still be alive and breathing. Statistically significant or not, that’s more people that the largest US football stadium. Imagine looking out on game day and thinking 1 drug could save every human life in there. I’d like to tell the FDA the same thing I tell my son...MAKE SMART CHOICES! Long CYDY!! Leronlimab saves lives!
Pease please PLEASE let this be the day we get a PR one minute after closing saying Lero has passed primary and secondary endpoints with flying colors for the S/C trial. T-minus 3 minutes.
There was an article about CYDY and another small biotech that is making a Covid vaccine. Someone posted the link on here a week or so ago. It was an article from Seeking Alpha. I’ve tried to find it there, but I haven’t had luck. Does anyone recall the article, and if so could you re-post the link? TIA!
I mean...If Nader’s mother in law is not at least on the cover of one brochure or a prime time commercial, then why are we even here?!? I’ve never heard of someone liking their MIL so much!! Also, LONG CYDY!! We are almost there!!
Question regarding “Right to Try” legislation that was passed I 2018...on CC’s Nader keeps saying it varies state-by-state. Does anyone know any details surrounding this? I do not live near a state that is near a study site. If I find myself, or a loved one, with S/C C19, what are the chances of getting Leronlimab through this bill that was passed? Does anyone know if NP has mentioned any patients in any states getting the drug through this channel? TIA!
NP keeps saying the “Right to Try” bill is state-by-state. Didn’t Trump pass this as a federal bill in 2018?
Proof? Where did you see that?
Did the Data Safety Monitoring Committee look at the S/C trial last Monday or on 8/3? Aren’t we suppose to have some info on that post 10 days? Does anyone recall what the post 10-day date is?
Also, has anyone been running a timeline on where we are with the uplisting?
Lastly, what are the chances that one of these other countries will approve before the US so they can gain earlier access to the vials already produced for 2020? TIA!
He was VERY firm in that statement!!! Come on FDA and give us the Leronlimab!!!!
What ITAF???!!!
Thank you for posting this!
My position is long. I just wanted a recap of the call??
Can anyone give me a recap? I’ve missed the entire call trying to work the World Wide Web from my crap internet service. Ugh!
This should be presented on tomorrow’s cc when the Q&A starts. If they keep receiving emails and doing nothing, then perhaps the wrong person is receiving the msg. Those comments were SPOT ON!
I think it will be during tomorrow’s cc. Hoping they have an update on their pending FDA mtg for HIV approval too.
Seems to me the safety data is excellent news. If far more patients in the M/M-placebo group are experiencing severe SAEs, the same is likely to hold true when the Data Safety Monitoring Committee’s upcoming review takes place on the S/C patients. If that is the case, I hope they are compelled to halt the study and approve it so no additional patients have to receive placebo.
Let the haters hate. When they contract Covid, wonder what drug they’ll be wishing they had a subcutaneous, home injection to take?
Motor on CYDY...Long and strong!
That is awesome!!
I like where you’re going with this!!
If Leronlimab is being studied as a PREP for HIV prevention, I wonder if, on down the road, it could also be studied as a “PREP” in patients that are at high risk for certain cancers, or a monthly PREP to lower chances of catching C19. I wonder how many of the 500+ HIV patients have developed any type of cancer or caught Corona during the years they have been on therapy throughout the study. A retrospective chart review would be awesome once we get the HIV approval. Sky is the limit!! We need to let this little tater-chip rip!! LONG CYDY!!
I have a question in regards to the manufacturing portion of pushback from the FDA....
Why does CYDY even need to include 3rd party needles and syringes in the packaging that will ship with the vials of Leronlimab? Couldn’t an HCP simply write a 2nd script for the needles and syringes, to be picked up at the pharmacy or shipped from a specialty pharmacy with the vials?
I don’t think he waffled on the BLA timeline. He stated that he will disclose the timeline to shareholders once they have met with the FDA for the Type A meeting. Or at least that’s how I understood it. I’m long CYDY. I believe in the science. I think if management can pull this first approval through, it will increase shareholder confidence 10/fold. I may buy more tomorrow.
Okay, so based on this protocol, then
1. Safety: The risks to human subjects unexpectedly outweigh the benefits because of unexpected severe adverse events.“Risks to subjects are reasonable in relation to anticipated benefits...”This determination changes when a study unexpectedly causes serious illness or death in human subjects. The study may then be suspended by the FDA, the sponsor, and/or the IRB until the risk-benefit ratio is reevaluated.
They unblinded the data a week ago and the current trial has not been suspended yet so that is a good sign..
2. Benefit: The study hypothesis is unexpectedly proven early within predesignated criteria. Continuing to expose subjects in the inferior arm to additional potential risks or keeping them from benefitting from the therapies in the superior arm is hard to justify ethically.
NP mentioned “several deaths” in his call last week. It would be the ethical duty of the FDA to approve this trial on interim data vs continuing to enroll 1/3 of patients to placebo if the disadvantage of receiving placebo is resulting in deaths and the advantage of receiving Leronlimab is life. So that’s seems hopeful.
3. Futility: The study hypothesis is unexpectedly shown to be unprovable within the constraints of the trial based on a statistical analysis of early study data, usually done at a planned interim analysis. In such cases, there is no benefit to balance against subjecting subjects to potential risks.
If there are multiple deaths on both sides and the primary endpoint looks unlikely to be met, then why would CYDY continue to enroll? That leads me to believe the majority are in the placebo arm. Last I heard enrollment has increased to N = 120ish. Really hoping statistical significance can be achieved on interim so no more patients are subjected to the placebo arm.
Maybe around 7/22 we will know more and the results with be stellar. LONG CYDY!
Anybody want to guess the time of day for Friday’s PDUFA news? Anyone think the company will release presser before the market opens or after it closes? Fingers crossed for good news at any time on Friday!! Long CYDY!!
Upon reviewing the interim data, wouldn’t CYDY be ethically inclined to stop the trial if several of the deaths were coming from the Leronlimab leg? Why would they continue enrolling patients if this were the case?
Has anything come of Citron/Left being investigated? Friday can’t come soon enough!! We need NP to get on the horn and spread some positive Leron-gospel!! Long CYDY!
I think you can also go to clinicaltrials.gov and look on the study design to see which clinics are study sites. Call those clinics, have your friend ask if she can get an appointment with one of the oncologists involved in the trial (possibly a tele-doc appt if the clinic is too far to travel). Her current oncologist could then send all of her records over to the study clinic for the new MD to track. There will be specific criteria she will have to meet to qualify for enrollment. If she doesn’t meet the criteria, the second option would be to reach out to CYDY and ask for compassionate use. Prayers to your friend!
I went back and listened on the severe/critical data. He stated that “quite a few deaths reported as SAE’s”. It doesn’t sound like there were any other SAE’s besides the death. My question is this...does the company know if the reported deaths/SAE’s were actually from patients taking Leronlimab or could some/several be reported from the placebo leg? Info is at the 4:54 mark on the video.
Is there a cc right now? Anyone have the link to get on?
Is today an all time high? Keep running with the bulls CYDY!
CYDY got on the map from Charlie Sheen’s media coverage. We need Shannon Doherty in the cancer trial. She was on GMA this morning announcing that her cancer is back. It would be a win-win...saves her life and the company gets more positive media exposure.
https://www.google.com/amp/s/www.health.com/condition/breast-cancer/shannen-doherty-cancer-diagnosis%3famp=true
Now he is saying END of Q3!