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More good news in today's 8k. Arnold Lippa, RSPI's main man and chief researcher, has invested 225k in the company. Very bullish sign.
Today is the day!!! Read the 10q. They received non-dilutive cash and the sleep apnea trial will proceed. A GREAT day for all longs who have been waiting patiently for this day. It will be valued at least around 20-25 million when all is said and done, given the Phase 2 trial for a billion dollar indication. Get ready for the ride.
Any idea when this is all going to go forward?
Re-reading the latest info, I think you are right. If they signed a CRO agreement, sure makes you think positively. But I have been burned so many times by this company....
Where is the financing coming from? That is the million dollar question. The link just shows a CRO to run the study. I hope you are right but RSPI needs NON-DILUTIVE cash. We haven't seen it yet.
Says who?
Big news! Looks like they are going to get non-dilutive financing thru Australian tax credit. Obviously RSPI thinks they have enough money to move ahead with the trial. We will see if they get any other non-dilutive financing but this is really great stuff.
What is the special dividend?
Good news on patent payments in 8-k. Eliminating and deferring patent payments. This goes a ways toward cleaning up the books. Still need non-dilutive money. Let's hope it's coming and this could skyrocket.
If they get non-dilutive funding out of this, stock will skyrocket. If dilutive, it will be dead.
Clambottler,
Maybe this info from another board will clear up your misconceptions.
Apparently, not everyone here is blessed with the ability to read a PR. Let me dissect it for those people again:
* "Zyesami Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival" => You don't claim that if it's not true, or you want to end up in court/jail
* "Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013)" => That means ALL 196 patients from all 10 hospitals taken together were evaluated according to the pre-determined primary endpoint metrics. This analysis has shown improved recovery from respiratory failure (definition of respiratory failure per the FDA) both at day 28 and day 60. This has no value like "number of days" or so attached because "recovery" is a binary event. But whatever the difference is, the P values tell us that it is very unlikely due to chance. Much better than the "gold standard" of P < 0.05.
* "also demonstrated a meaningful benefit in survival (P under .001) after controlling for ventilation status and treatment site" => Let's get to the controlling part. That means that you normalize your data in a way where you try to eliminate external factors, so that the results really reflect the effect of the drug you're studying. ALL patients get the adjustment applied, placebo or treatment alike. Adjustments need to be scientifically valid and usually are agreed with the FDA. Severity is one of those external factors that are expressly encouraged to be controlled for in FDA guidance. Adjusting for ventilator status (HFNC, positive pressure, ventilator) IS adjusting for severity. Adjusting for treatment sites (tertiary vs. regional), when some are over 200 % ICU capacity, seems like a very valid external factor not intrinsic to how the drug works as well. The adjustment is for the mortality evaluation ONLY. All said and done, the treatment arm did better than placebo AND that fact is less likely to be down to chance than 1 in 1000 (P under 0.001)!
* "In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals." => IN ADDITION to ALL PATIENTS mentioned above, we'll now get more detailed data on a subgroup. Those patients previously mentioned in the 28 day interim readout. Those that haven't progressed to a ventilator (which nobody will hopefully have to do once Zyesami is in hospitals), those which were treated at hospitals that had enough capacity around and at least a specialist on call at all times. Basically the most meaningful patient group to really show what's going on with this drug biologically in a patient.
* "In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). => In other words, that's a clinically meaningful improvement in getting off assisted breathing, which is very unlikely to be down to chance. So the drug works.
* "Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007)." => Yes, the tertiary centers do a good job now keeping patients alive. Much more than the 20-30 % rates being circulated on the CYDY board for example. But with Zyesami and good care, when you go to a hospital with critical COVID, you have an 84 % chance of surviving that now for at least 60 days! That's bigly. COVID will be a flu soon (especially when we get the inhalers out).
* "To the company's knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial." => We're the first. The one. The only.
* "On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration ("FDA") for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA)." => As stated in the conference call, we have the data we need IN HAND to apply NOW for EUA. Dr. Javitt is no amateur with the FDA. And, he even thinks this RCT will serve as the basis for a New Drug Approval, because ALL ENDPOINTS WERE MET! This was a blazing success!
Less
Bullish
JB or anyone else think there still might be a merger with RLFTF? I'm at a loss to understanding why it would occur at this point.
Incredible accumulation. 500k blocks trading. Wow. This has been going on for 2 days now.
JB,
Any thoughts about what the price would be for ACER by RLFTF>
Someone accumulating big time. Level 2 bid for 928,000 shares. 800k purchase last week. Get ready for take-off!
Incredible 880,000 buy at the close. Someone bought about 1.3% of the company with that trade. Unbelievable. Makes you think someone knows something. Will see how crazy this gets tomorrow.
JB,
Can you explain how they could get positive results and the price drops? What am I missing? TIA
KGROMAX,
Isn't evaluating patients who are alive or dead at 60 days an important metric and also easy to objectively measure? Wouldn't that mean something to the FDA if there is a significant difference? TIA
I appreciate your expertise. Does RLFTF's meeting so many secondary endpoints, especially getting HFNC patients out of the ICU so much faster, make a difference for an EUA.
Also, RLFTF claims they haven't had the time to determine cessation of respiratory failure. Is that possible, given the ambiguity of "respiratory failure."
JB,
How optimistic are you? TIA
JB,
Any idea how soon that PR will be released, and how great is your certainty about the share price increase? TIA.Your insights are always appreciated.
tcm,
What is the advantage to GEM or anyone else of having NeuroRX and RLFTF merge with separate partners, instead of both merging with the same one, perhaps after NeuroRX and RLFTF merge. I can't figure this one out.
J-B,
You said BRPA and BRPAW will move closer. Is this because the merger is more likely in light of the document filed with the SEC? What would be the reason for RLFTF and NeuroRX to get to the Nasdaq separately rather than together? I don't see the advantage to GEM (who I suspect is controlling things to some extent), who has such large stakes of both. Could you help by explaining? Do you still think RLFTF and ACER merge? Thanks in advance for your always helpful insight.
JB,
Thanks so much. Your insights are always so welcome.
JB, help me out here. You said they will all hit. But if RLFTF decides to merge with ACER instead of BRPA, doesn't BRPA drop back to $10? Also, do you think ACER will get a cut of RLFTF's profits or does their deal just give RLFTF a percentage of ACER's profts but not vice-versa? If the latter, then ACER will not really profit from RLF-100 success. Thanks so much.
Going nowhere quickly. No Biotech Conference news.
J-Belfort
Any idea if RLFTF will release EAP data before they release the RCT trial data? If so, any idea when? TIA
J-Belfort,
You mentioned "exponentially increasing amount of EAP patients, that data might get to us soon." Do you think that will make any difference to the FDA? Won't they still demand RCT data before granting an EUA? If so, does that data really matter? TIA
J-Belfort,
Any idea of when RLFTF will release data of 175 patients from compassionate use. Seems like it would only help get an EUA. Appreciate all your insights.
Tough times coming. Sorry to all longs.
Big Pharmas flush with cash. RSPI has billion dollar sleep apnea drug awaiting Phase 3. Another drug for spinal paralytics that would be worth 100s of millions. And now a refractory seizure drug that also could (I emphasize could) be worth 100s of millions. At this ridiculous market cap, buyout would make lots of sense for everyone. Management owns lots of shares. JMHO
Big news coming, with multiple drivers. No one has been following this while managers have been working quietly building up value. Several pieces of news to come. Gotta love this management.
Bet on this management!! Have been in this a long time.
Have followed this for years. This is a blip that will be corrected; always happens. Sorry to be a downer.
Prospectus today mentions Reg A offering. This is a great move to raise more money. This stock will do very well with (not much) money to move along the programs: 3 shots on goal with the three different programs.
J-Belfort
Do you think the FDA will withhold the EUA until the study is completed? I will be disappointed if that is the case, given that the EUA is supposed to be given for drugs that could possibly prove efficacious despite not having final results. There is no other significant therapy for the seriously ill. Seems somewhat cruel, in light of the increasing number of victims.
JB,
Do you still think the EUA is a done deal? Also, you alluded to an offer RLFTF had recently received. Any idea of the price of the offer? Thanks much.
As I warned yesterday, lots of day-traders pumping this. Some bought it and have paid the price.
Pumpers are here! Beware! There are new posters here who know nothing about this company. This is not a short-term play. This is about buy-and-hold, for a long time. This upsurge happens every 6-8 months, and then the price settles back to where it was. None of the posts in at least the last week have anything pertinent to offer. So newbies be careful. You will get caught in the correction, which is now taking place. Day-traders have driven this up and they are now driving this down.
If you are patient, and are willing to take some long-term risks, then welcome.
JB,
What do you see as a buyout price (per share)? TIA