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Certainly didn't say that they are hiding/misusing the raised funds.. I said I thought they should be continuing the IV Trial until complete, OR until RLF receive other info from the FDA. ALL the other COVID drugs ARE following the normal Trials path. ALL other drugs are subject to Blind-Placebo arms. Many treatments for COVID, Cancer, other terminal ailments are physically tough, especially when in a Terminal health condition. Did youall look at the Treatment map Tif posted(*). Or one of many other evaluations containing data on current Trials. The days of a Rem/ coloquin and antibodies pumped by politics seems OVER to me. Publicly relying on some inside FDA board help is almost criminal(?), IMHFO. RLF raised the money for Trials and partnering for production/logistics etc. Cant understand why anyone would support not finishing at least the Phase 2b side of this 2b/3 Trial. Stronger / MORE data is always better, IMO. But it's a free speech country, your welcome.
BTW Aviptadil is not even on the VIP string, that is another company.
Tif's treatment map...
https://racap.com/media/Covid-19/COVID-19_TX_09302020_F.pdf?v=O7RntLhd29chARXm5ScrGTR3-P2jpMyn6M-RViFJeQA
Cclr and your MC predictions.
Ifen***dil, in phase 2b/3, expecting full enrollment eminent, initial data readout 15 days later.
See the treatment map Tif posted a while ago...You asked.
So $30B? $45B? Better check MC of other actual Biggie Pharmas. That will be a pretty long road..JMHFO...
They raised the money to complete Trials and apparently set up subcontracts/partners.?. $400k out of $30+M? BFD. Continued Data and Results are a BFD, IMO. Sitting on their laurels when all others are following the FDA Clinical Trial path. ummm?/?
Until unmasking request, all data is blind to all. Just safety and futility are actual FDA considerations at phase 2b. Shorting the patients available and including Placebo comparisons dont match up. Should be continuing recruiting into the Phase 3 portion until DSMB says different, IMO.
BTW, IV is the only Trial going on or approved for EA. Inhaler Trial is EU and here not recruiting, Right? EUA request is IV, Right?.
Just saying there are a lot of Drugs in Trials, some beyond phase2b. EUA seems possible maybe even probable, we hope. They certainly raised the money to continue this Trial. Nothing is being done/no one dosed since the 102nd patient 9-30? Just blowing off the rest of this IV Trial seems overconfident. Too many / all others following the FDA Trials path. FDA is now staffed with new Big pharma folks. I dont expect inside preferential board help. Yea, just keep working and gathering Data like all others. Apply for whatever but continue the work available / in process...
AMG, I dont see the post/posts you're concerned about... Open forums are exactly that.
I'm Not confused, just stating Obvious facts about what a 2b/3 Clinical Trial is and that All the current companies with the huge variations of MOA etc are following Normal Clinical Trial paths.
Ifenprodil will be judged by successes in Clinical Trials just like ALL others should be. No inside dude sitting on approval boards. Just plain Proven Science from Clinical Trials.
BTW, I doubt many are making decisions on what I write on Ihub, or You either.
A petition was Not my point. I asked the question at the recent presentation blog and could see several similar questions posted.
RLF raised $30M+ from the 400M shares to GEM recently, to continue Trials and start operations after the 'partnership' with NRX. It's only $400k for the VIP (their price obviously less) drugs and then administering it.
Nel, there are Plenty of patients now to complete enrollments. They deserve treatments. Cant figure why you say April for data/Trial completion except that they aren't enrolling anymore.?. Also cant figure why they're stopping at 102 in the phase 2b of the 2b/3 IV Trial. Sure great data, BUT. Look at the FIELD of companies going thru the process and the MANY different approaches being tested and their value Proven or Not, ALL thru full normal Clinical Trials' progression.
I dont count on inside help (Harris?) at the FDA, especially whit the current state of political confusions they are dealind with. All JMHO.
Those 40+ patients are dying now. Maybe 27+ more could be saved. I think it is unethical NOT to be continuing the treatments/Phase 2bTrial.
A 2b/3 Trial normally completes the reviews of the 2b then progresses to a Phase 3 with a much larger group for "statistically significant" data.
EUA probable, overall approval unlikely, IMHFO...
Yes I know personally how entering a Clinical Trial feels when there was a 33% chance of a placebo. Many more DIE from Cancer than Covid. 40 more patients? OMG 2nd time. NOT 'unethical" to finish a Trial. Plenty of time. Plenty of Patients that Could be helped. Now just sitting back waiting???
Ipillmumab/Keytruda/Optivo. Yes I know Exactly how it feels to be in Trials AND I SURVIVED... Yes it's personal.
Gee folks (tiger) it's not *millions more patients, it's 40+ more patients. OMG...
When the FDA says that, Great. I'm buying more. You mentioned the Volume, maybe others not posting/trading here have this question/ caution too.
OR the most common, "Continuation of the Current Trial is Allowed". I heard what has been said by Dr JJ. Stoping work/Trials before review is goin "all in". Why NOT finish recruitment and collect firmer data?
Noticed that and even after the recent news.
BTW We have not seen posts from Any of the moderators and certainly Nothing to UPDATE the Intro. Pretty slack involvement for them. NO DD, and even No"cure".
Thanks to the few carrying actual info and opinions to this forum.
They discussed hiring/partnering with a large logistics firm to dispense better.
What I dont get is why they wont attempt to finish the IV Clinical Trial. Just "OK got some good data on 102, we've done enough, dont need 150, in their opinion".
Are they going to settle for EUA only. Its a "safety/ futility review with a "go ahead with more Trial till finished/ stop for S or F / Enough data on you unfinished Phase 2b-no Phase 3 needed". They should have finished recruiting and finished the Trial, IMO. I dont like Their going all in with an unfinished Trial, JMHFO...
Hope their new CRO guy gets patients enrolled to finish that Trial and does better with the Inhaler. Sure Phase 2b Placebo Trials are tough, but not finishing this Trial? Maybe they'll at least get the EUA, BUT???
They appear to be 'all in' that data from the 102 patients' of the 150 2b-Trial will do and then developing the market thru IPO / merger / partnering / subcontracting.?.
With NRX a different private company how are 'Profits' to be measured for the splitting the 50-50/85-15% agreement? Overhead? Getting complicated for the common shareholders to see when a 'profit' is made, IMO.
But. If we're lucky, IMO, maybe an actual Biggie will want the whole group package at a price. Bonu$E$, C-O-C and Jobs for the top dudes, of course.
A choice from the above needs to be done ASAP as we all see the many avenues working on the COVID issue. Time=$ and lives. The Cocktail of drugs' has gained support lately, IMO. Only two VIP drugs in Trials using different MOAs. So many folks chasing Mabs/antibodies/virs. It's good to be one of two with this VIP approach.
Not buying more yet or flipping.
When there is 100% enrollment maybe Dr Wiliams can suggest his opinion of the accumulated data so far. The Trials are pretty, Primary outcome 15 days and Secondary outcomes 1 to 28 days...GLTA...
https://clinicaltrials.gov/ct2/show/NCT04382924?term=Ifenprodil&cond=COVID&draw=2&rank=1
Thanks for filling in details and possibilities. There should / has to be a 'fit' for RLF in this. DrJJ spent a lot of time on RLF during the presentation. There is still a 50%+ chance the FDA may say continue the Trial and present full data.
I like the scenarios in the previous post and I have said, buyout or ? Taking care of our OS into a new entity...
The USA is the Major market when dispensing starts, we have most of the sick. 10 employees with only 1 CRO guy starting in Sept as CMO and 1 at SA Board. Nrx also top heavy too, IMO. Development/cost$/logistics(?) of RLF-100 IV will be handled by RLF. I dont see where/how RLF fits into the new scheme of NRX/NYSE Bio co.
All eggs in the 102 patient review and not even talk of completing the first part of the IV 2B Trial, and nothing on amount of patients needed to reach statistical significance with the Phase 3 part. Seeing the last FDA update on approvals seems to show Full Data is King/Queen/Game or dont apply, IMO. Huge amount of 'Hope' for FDA EUA, general approvals on the 102. Guess Dr JJ/NRX feels no need for further plans. Kept pushing the 21 data.
EOD volume at SIX/here ? anyone have an opinion besides me. Price after this news.
The last capital raise for $34M costs 300M shares from GEM and now pre list the plan is to raise another $50M pre listing and $100M post listing with some kind of merger/etc. At GEM's rate how many new shares are they talking about.
Well they need help to do all this. But new projects?
Skipping the PCP etc stuff'''
@15;50 ?
$9K to $16k per patient for IV
Last slide same as the first, capital raise.
https://www.streetwisereports.com/article/2020/10/08/streetsmart-live-presents-algernon-pharmaceuticals-inc.html
Yea, Sorry, I've got corporal level IQ and chemobrain, Streetsmart on Streetwise duh. Whatever, good segment, 10-8. Dr Dwain hired 10-9 ...GLTA...
The CEO had both of the Private Placement investors and Dr Dwain as guests at the last Video conference on StreetSmart. Wonder why the CEO moved to that Platform with Those guests. Watch it, thank Smoki for the tip...
Been here a long time but still here ++. I make my own decisions and factor in all things, IMO.
A possible contribution to the COVID fight (etc) is much better than an imagined breathalyzer.
You have mentioned the 'door' that the EUA and EAP open. This route is the best and fastest way to garner support, IMO.
I attempted to discuss the difficulty of recruiting using a personal experience.
Inundated for the EUA is different than being part of a Drug / Placebo Trial. The life/death decision is amplified when a possible Placebo is involved instead of getting Any other possibly effective Treatment for sure...JMHFO...
I did cancer Trials with difficult courses, it's hard for doctors to recruit even when patient risks are high and Some treatment is desperately needed. The chance of going thru the infusions/efforts yet getting a Placebo is dissuasive, at the least. Many wont do it.
Nebulized Inhaler will much better at recruiting, IMO.
The word spread for Rem still will garner many patients despite a whopping <5% (11%) effective record.
All news from either company is important, IMO. Thanks from all/me...
Sad follow up to yesterdays bump/news, low volume and in the wrong direction so far. Your charting has been fantastic. Its needed reality. I can barely figure out my basic load much less try to make sense of it and the "news" too. This old corporals doesn't flip because I'm too dumb (taxes?), just buy-hold-or sell with some fore sight, preferably not hindsight...GLTA...
All news from either company is important, IMO. Thanks from all/me...
I did not want to register and we all would appreciate if you can pass on the 'meat' presented.
Why a private venue, wouldnt CNN/FOX be interested in an EUA? 20 minute presentation then Private 1 on 1? I cant find an access to past interviews/presentations. Equity Raise and IPOs?
Solebury Trout provides investor relations, corporate communications and market access to private and public companies across industry sectors. Solebury Capital advises corporate and financial sponsor clients, offering independent advice, experienced judgment and transaction management services during the capital-raising process.
Solebury Trout is affiliated with leading equity capital markets advisory firm Solebury Capital, which in 2017 advised on nearly 40 percent of the IPO proceeds in the United States.
Dr Dwain was added to the Medical Advisory board NOT the Board of Directors.
Probably had to pay him for some work/research etc with a second opinion on non public info. CEO, Dr Swain and the main two PP investors just had a StreetSmart stream.
I wrote GDS and thanked them for the recent strong enrollments for Ifenprodil.
Glad to have Dr KSS on the Advisory board, I'm sure Dr Williams has discussed some issues with him and valued his opinion. He has been invested in AGN since ahead of IPF Trail, according to recent StreetSmart video. The PP investors were also there.
My gratitude to those with opinions and replies. I guess examination of my past opinions and linked references garnered attention. Oh well, bought @$.45s and sold enough @$.68. Maybe I'll buy more buy, maybe not. I wanted a buyout in Aug and still think a buyout in Nov is better than the long road... Free country,
you're welcome.
You called up a post from early August and the site updated 8-31 with (Inclusion and Exclusion) criteria and other changes.
In the video Dr. JJ discusses how an Inhaler version is not better than an IV for the sickest patients and why. He differentiates RLF-100 from a competitor's pb1046 affects and why.
I guess he feels asking/unmasking data from the 102 (+?) at the end of the month and submitting to the DSMB. I thought that a Full Trial recruitment was to be announced 9-30.
https://clinicaltrials.gov/ct2/show/NCT04311697?term=aviptadil&draw=2&rank=2
Answer; another *dil -phase2b/3 announced strong recruitment 9-30.
Answer; dumb old corporal 4X cancer survivor, loves MJtea not infusions, promotes whirled peas and science, recent new ID.
2.5B+...
Wow good find, did you read the rest of my detailed post with links to CT.gov and my reasonings; that IV trial is not same patient condition as EAP? Mild to moderate for that IV Trial while other Trials looked for sickest. Exclusion Criteria for IV CT stated many limitations on patient health.
Thats why my comment. Other Drug Trials I noted were seeking the sickest patients back then, while RLF IV was not. Still skewed, IMO. At that time DSMB allowed IV CT to continue after 30 patient review of safety/futility.
EAP was just granted then. They also in house partnered instead of selling for $2-4B as I suggested. I only have free shares after 9-30 and have not been convinced to buy more again. JMHFO and actions...
102nd patient on IV Trial review by DSMB is the same. JJ said review has 4 possible outcomes and hopes to have info 28 days from 102nd. 102nd review is Not on CT.gov.
Today pps drift after Topline data???
JJ said, in EAP the control patients most had underlying conditions. Also listen at ( 7+14+31 min).
IV Trial..."Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
Only data JJ can speak on is safety-futility, Not actual findings at the Trial. IMO. Outcome assessor and Investigator/Drs will do that at end of Trial. Big Pharma is stacked in FDA now, per Dr JJ, Paper he wrote for EUA is already done... All-IMO, from what was said, posted on CT.gov...
Thanks for a reply. I did listen and read and present REAL linked info. What JJ is claimed to say and what is Posted on CT.gov dont match. No one will know about IV CT until data is reviewed from masking criteria. 102 isnt even a point at the trial info, 30 was safety/futility and 102 is a second (agreed to by JJ) same review/enrollment update. IMO. Maybe I'm wrong...
Emergency use may happen soon on Expanded access data but IV Placebo Trial data wont be known by anyone till complete. IMO. Just facts from THE source with MY perspective
Maybe others feel the same way, Volume=Price... I hope we all can agree on the extremely LOW bar set by Rem. Plenty of room now confirmed for actual Successful Treatments to move forward...GLTA...
EAP was 21 treated + 30 untreated with data in today's top line PR. Great success.
I still dont think anyone has access to the current IV data, see masking. IV Trial will need to complete for that Data. IMO. So, this top line data will be also sent for Emergency Use application. 144 patient data to be evaluated by Outcome Assessors at the completion. 30 patient safety/futility done and (agreed on) 102 review next step till full Trial completion.
Nice bump this AM, will we see the Volume needed to hold and gain?
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter trial, initially conducted at a single center with a safety/futility assessment following enrollment of 30 patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized, placebo-controlled trial with identical drug and placebo infusion bags
I Dont see 150 t0 250 patients and as of 9-30 102+. Note masking, how do they know results?
EAP was 21 with data in works.
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter trial, initially conducted at a single center with a safety/futility assessment following enrollment of 30 patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized, placebo-controlled trial with identical drug and placebo infusion bags
A lot of what if's there. Why the slow enrollments then thru Aug/Sept? Why are the tea leaves so clear for them with the IV data barely collected or peer reviewed? and now "submitted" not only for the EUA? How can there be significant statistical Data?
I think planning on some magic express route while so many Biggies and others are fighting up The even playing field of Clinical Trials, All to prove viabillity as a contribution to the solution of the COVID crisis, is shallow planning for RLF.