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FDA asks Merck for more data on therapeutic study. https://finance.yahoo.com/news/1-merck-says-fda-requires-230330058.html
Looks like they had 243 enrolled from what I can find. That's a little worrisome, if the size of the study was the only problem.
https://www.merck.com/news/merck-announces-supply-agreement-with-u-s-government-for-initial-doses-of-investigational-biological-therapy-for-the-treatment-of-patients-with-severe-and-critical-covid-19/
IV Trial Complete (link to changes) https://clinicaltrials.gov/ct2/history/NCT04311697?A=20&B=21&C=merged#StudyPageTop
Relief and NeuroRX are in a partnership. NeuroRX is the company running the trial and therefore reports most of the news and explains how the trial is going etc (Javitt is the CEO). Relief holds the patent for Zyesami/Aviptadil. This board often speaks as if Javitt works for Relief because for better or worse he is the defacto face for both companies.
Great PR! Funny to see the same information written two ways today. One in a hit piece and the other in a PR.
We're back to .40 as I write this!
Endpoints put their associate editor, who is 2 years out of college on this piece. She already had to edit the article because:
A previous version of this article stated upon second reference that those in the placebo arm were 35% more likely to recover and be discharged in the hospital. A correction has been made to reflect that it was the aviptadil arm.
Nice job Nicole. Nice job Endpoints.
Turdblossom. Some of have said we don't need to reapply because we applied with our data from the first 21 patients and were denied and they would approve the same application. But I don't think thats right. I thought we had to reapply after our current IV trial results for a new EUA. I also thought Javitt said in his Dr. Yo interview something to that extent. But someone please fact check me if they know for sure.
Either way I added today. Almost to 200k shares @.34 average
Yep, no way of knowing. I'd have to imagine it was rather mundane reasoning and everyone who has an active trial is waiting on approval received a copy of this document prior to you and I.
However I think the more important thing to note is that we didn't change the endpoint because it was a failed trial as some would have you believe. Most likely we just received updated requirements from the FDA and updated our trial accordingly.
Does anyone keep up with other trials that would know if they changed theirs in a similar manner recently?
Good find. Looks like we just updated our trial to meet these endpoint recommendations and not that the FDA was letting us revise our trial so it reflected an endpoint that was advantageous to us.
My TDA says +1113% premarket, I'll take it!
We made it to the front page finally!
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker
FDA 26th meeting:
The committee will meet in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement#event-information
However I don’t know if that’s the headliner and there are opening acts, so to say. There is also a meeting March 5 which seems much more likely we would be able to submit our information in time for. If you look at their submission process I don’t think we could make it by then. March 5 even seems soon.
FDA advisory committee meeting Feb. 26
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement
There is also. Meeting on March 5
Peer Review Article out: https://www.researchsquare.com/article/rs-191980/v1
Added 20,000 here!
Re: Todays Meeting. With the volume, and PPS increase. Do you feel like they had a meeting, but it was for big investors and JJ accidentally shared it with everyone over the weekend? Am I just making things up at this point?
Whoooa, here we go!
Devils advocate. Anyone worried that the news is not good and JJ is sent out to calm us and explain what happened? Or is this just my anxiety creeping in?
Scenario 1: news is great, JJ will tell us all about it and highlight the data. Then explain what next steps are for EUA or approval with an update on the inhaled trial, the new company we bought etc.
Scenario 2: news is not great and JJ is going to paint a rosy picture and tell us about the new company and their hopes for that and their hopes for the inhaled trial, in an attempt to keep the stock price from falling through the floor.
My 160,000 shares are betting on scenario 1. But it’s always a risk isn’t it?
Nephron Pharmaceuticals expanding (link). Contracted w/ Relief.
The entire team at Nephron is excited about the expansion progress we see when we come to work.
— Nephron Pharmaceuticals (@NephronPharm) February 1, 2021
CEO Lou Kennedy set ambitious goals for each expansion project, and those goals are being met, many of them ahead of schedule, every day.
🚧🦺🏗💥🏗🦺🚧 pic.twitter.com/TkQVbR1PnJ
It is tough and I definitely roll over in the night to check my phone for those 1AM PRs. But I honestly think it’s going to be a few weeks. I’ve said this before in this forum. But for any of us who have office jobs or own a small business, think how long it takes to accomplish milestones or do a big press release. Nothing happens in a few days. A few weeks, minimum is the reality. And what if it were a major rollout of your only product?? That may take a bit to make sure you get it right. Right? So try to relax if you can and buy some dips because this is going to slowly sink lower over the next few days and weeks as flippers move on because we are waiting.
Uncle Gee gee! I think. Bring him back! Even if he was faking it, he really seemed to k ow what he was taking about in terms of what the stock might be worth after EUA.
I’d like to talk through the attack angle with people who understand this better than myself. That certainly either seemed like a coordinated attack or someone bought 3-5 million shares at once and then burned through everyone’s stop losses? We are all so excited (myself included) that this signals the end game. But, to the more experienced folks, does this look suspect?
Someone had an EUA spreadsheet and analysis here a while back. He used to post all the time. Daddy something or dad something? I can’t remember. Did he post that anywhere?
Yeah I just happened to be at my computer. I've just seen it jump like this on no news and I never took advantage so I was determined this time. All I did was buy more RLFTF though. haha! GL
I finally sold a share of RLFTF today. I've been holding since August and tried to take a little profit at .75 knowing it would come back down on no news. I only got 6000 shares off before it went down. I'm 3% lighter and looking to refill!
Sorry I know no one cares, I just got excited.
So I’m bullish and excited for Lenz. But what would you say to someone that says the cytokin storm is not the problem. I’ve just been reading some articles recently and I’m getting opinions? Thoughts?
Seeking alpha had a particularly damning article, although often their free articles are garbage.
Aviptadil is also listed as an "Active Pharmaceutical Ingredient" on Dr Reddy's website. Search this PDF from September 2020 for Aviptadil.
https://api.drreddys.com/sites/default/files/2020-10/Dr.%20Reddy%27s%20API%20Product%20List.pdf
You're completely right. I noticed the trend as well and was going to sell some in premarket this morning. But with the news being so good, I thought it might actually trend up during the day. Should've followed my gut.
Today's news pairs very well with Biden's Executive Order on Improving and Expanding Access to Care and Treatments for COVID-19 from yesterday.
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-improving-and-expanding-access-to-care-and-treatments-for-covid-19/
WOW! Some of that is potentially very juicy! I mean we already had fast track, etc. But there seemed to be an emphasis on removing any roadblocks on existing therapies! Exciting!
Maybe I’m a sucker. But I’m loading up!
40'S! I could cry!
Someone tell me I'm wrong. But if I read the PR again. It reads to me like it has been cleverly worded to make it sounded like HHS and DOD asked Relief to participate in this. But if you read carefully it just says that they put out a public statement saying that treatments for critically ill was a big need. Also the I-spy website is horribly outdated and doesn't mention any of this, nor their link with HHS or DOD.
Read these two paragraphs. I'd be happy to be wrong.
The inclusion of ZYESAMI™ in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense for investigational drugs capable of targeting the most acutely ill patients with COVID-19. ZYESAMI™ has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for the treatment of Critical COVID-19 in patients with Respiratory Failure.
In December 2020, Dr. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, issued a public statement that "Through our Operation Warp Speed partnership, we have worked feverishly with private industry to develop and make treatments available to reduce hospitalization, either shortening the length of stay or treating people with mild or moderate COVID-19 infections before they have to be hospitalized. While we're making significant progress, treatments to save lives of the sickest patients, such as patients in intensive care or on ventilators, remain an urgent need."
Thank you J-Belfort. That’s what I wanted to know. I didn’t know if you had to apply before they would review it. Or if they would just review the data on their own.
So we were denied our EUA for the first 21 patients. But have we filed for the IV trial? Or do we have to wait until the trial is over and the data is out to file an application for EUA based on that data?
Has HGEN filed for an EUA yet? I’m sure most people know the answer, I just haven’t been as up to date.
Been here since .06 and just added more!
This is potentially ignorant of me because I haven't been following this as closely. But has Hgen even applied for a EUA? I see everyone act like its going to get dropped in our laps at any moment.
Its definitely because I sold this morning.
I sold some shares, this is gonna fly today. I took some profit this morning, so this is going to fly today. You’re all welcome!
Stocktwits! Great Penny, I'm watching. Now lets get this rolling!