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$BPSR FDA Approval News Transcript. This is an absolutely HUGE “market” for BPSR.... note the bold .... Very impressive IMO. Wait for more media exposure.... tick tock tick tock ;)
FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin™
MIAMI--(BUSINESS WIRE)-- Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) granted expanded access for an intermediate size population allowing its proprietary therapeutic, Zofin for the treatment of COVID-19.
This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient and inpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease. Aside from Convalescent Plasma, Zofin, is the first reported acellular therapy which can be accessed under FDA’s approved expanded access program. Zofin is manufactured to retain naturally occurring microRNAs, without the addition of any other substance or diluent.
This recent FDA approval follows the treatment of six outpatients treated under emergency INDs, who have reported significant improvement after being treated with Zofin. Organicell is currently in the process of enrolling moderate to severe COVID-19 patients for a Phase I/II placebo controlled clinical trial (NCT04384445) to evaluate the safety and potential efficacy of Zofin.
“Treating patients in an outpatient setting may be critical in helping to prevent the progression of the disease and further hospitalization which could lessen the impact on hospitals, thereby reducing medical costs,” said Albert Mitrani, Chief Executive Officer of Organicell.
About Organicell Regenerative Medicine, Inc.:
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Maria Ines Mitrani, Chief Science Officer. To learn more, please visit https://organicell.com/.
About Zofin™:
Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.
Forward-Looking Statements
Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as “will,” “believes,” “expects,” “potential” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20200929005377r1&sid=acqr8&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20200929005377/en/
Jeffrey Freedman
RooneyPartners
646-432-0191
jfreedman@rooneyco.com
Source: Organicell Regenerative Medicine, Inc.
© Copyright Business Wire 2020
Fantastic FDA approval news this morning. Grabbing a bunch more here under .30 since they’re giving them away. Gap closed ! Let’s rollll $BPSR
Yessir. Going to be amazing. Nice trading here too. GM & GL
Is THAT what it said? Shit I gotta reread lol.
“Research and development of undiscovered properties of cannabinoids for the treatment of inflammatory & chronic diseases.” —
That DOES sound exciting. Very novel. Nice catch. Gotta be another U of Pretoria endeavour I’d imagine; and, speaking of that, we’ll likely see more of these peer-reviewed studies on medicinal mushrooms & psilocybin, but from the sounds of things they’re doing more with cannabis than meets the eye....
Lots of PhDs and MSc’s working on this stuff I guess. It would be sweet to see something totally random & out-of-the-blue on that point you located there, Supergarvis. There is a lot of room for R&D with these sweet plants & fungi !!!
$WUHN
Weeee. Dollars come quick.
CMPS bagholders will be coming here. More Psychedelic $$$ comin’ !!! :))
Agreed. Fantastic post.
That’s a nice sign, since she was down .57-.65 in prior sessions. Possibly ready for our move up.
I’m hanging in for tweets & website update & order news etc.... We have had a really nice cool down period here, imo.... I’m glad they’re not doing the whole “carrot-on-a-stick” thing .... “few more days... next week bla bla.” I prefer dead silence, quiet bidding, and then a substantive release.
I would like to see the new website go live & see a PR same day on some PPE orders. Good on them to pivot into PPE & hanging onto Laughing Frogs etc....
I hear ya loud and clear. Sometimes writing or typing out this stuff helps remind me why I’m here, being patient. But it’s certainly not easy sometimes!
GL & HF !!! $DKSC
No that is some bullshit article from an idiot on twitter. When you click on it, none of that appears. No such thing happening here.
Just exercising patience like the Wuhanian Warrior that I am ! Lol ;) $WUHN
There’s the .61
Yessir and if they didn’t exercise them it’s like “WHY?!? Don’t you BELIEVE in your project!?!” ...... Very nice validation IMO
I’ll say... wow... a reminder that “less is more” haha... I think I’ll shut up for a while and go back to reading / studying.... Gk
Yes, absolutely. We need dollars for that scenario. Market cap has gotta appreciate through price movement (buying), and not an increasing OS :). Anyway, something here for traders and investors alike. Those with the foresight and fortitude will hang on to a sizeable position for the endgame. IMO.
$RLFTF
Yeah and absolutely nothin’ wrong with that, but I know what ya mean.... A poster asked a question about efficacy for influenza as well.... I think it will be amazing to see the full scope of RLF realized here.... and hey it helps with ED ;)... lol.
Yup. Just buy and never sell, and eventually some 300bln dollar biggie will buy the whole ship & crew. Haha! Normally I wouldn’t think of that avenue but I have SEEN it so many times and have missed it. Sounds like there is a strong core group of holders here that will just watch this thing blossom and hang on for a potential buyout scenario or whatever.... I can’t wait for the Dr. J interview on Weds.... OH and tomorrow night’s debate right ! $RLFTF
Thanks Unc Gee Gee ! I love the banter ... Overall we have a very kind group here from what I can see. I have learned a lot by following the DD graciously provided here. All the best ! $RLFTF
Thank you !! :)
Yessssssss Green days and Green (k)nights ! ;)
Ready to go anytime ! Haha :D
That is a sad and sobering read.... Thank you for sharing. I cannot imagine the pain your family is going through.... Please take care of yourselves down there... I hope that they can make your father comfortable at the very least. My heart goes out to you guys....
Hey man I am very sorry to hear that about your dad in the VA home.... Thoughts & prayers out to you guys...
Thanks for your thanks :) Have a great day !
Exactly. If he DID NOT exercise that option, I would be asking myself “WHY the efffffff did he not take those shares???” .... that would be a red flag.
Just chiming in with my .02 here —- it would have that “8%” effect IF these shares were to simply hit the open market (float), but as Pc says there, we gotta look at the whole outstanding and when we see that GEM owns 30% (amazing), and that this is a negligible increase to the entire OS.
In short — these shares are not just slapped onto our float immediately with warrants being exercised; GEM can trade those shares into the float in accordance with the rules of the agreement, however much they’re allowed to “leak out” , how often, etc. So we can’t just say “this is why we closed at X on Friday,” as much as we’d love to make this as formulaic as possible....
Anyway, it seems to me that GEM wants to stick around with a large % stake and watch RLFTF go “seed to sale,” so to speak.... and likely get bought by a BIG Pharma Cowboy. This is my thinking & the reason why I’ll keep collecting.
IMHO !!!! Hope that helps... always learning myself
Thanks for that — so they own 30%. Largest shareholder. Gorgeous. Why own SO much of something that isn’t going to bring an absolutely stunning return?? Why keep doubling down?? ;) I LIKE IT
It’s like 50million shares for GEM, who has been investing in Relief for several years. Small potatoes on the OS so I don’t see it as being “railroaded by dilution,” but I understand what you’re thinking here.
Capital from GEM helped RLF do what it needed to do to get up on QB and I just believe that now they have cash in the coffers to roll this thing out with NeuroRX and bring us up to the Nasdaq. I don’t care that the OS went from 2.3billion to 2.8billion. If GEM wants to part with shares at .60 then that’s fine and IMO those will be absorbed quickly. Sensibly I would think GEM would like to see the SP gain traction, get over $1.00 and up-list before letting go of many. They are the largest holder and have been putting in lots of cash. Also the press states that they don’t need anymore cash beyond this to complete trials & scale RLF so I view that as a very good thing. Let’s see them stick to it.
Don’t get me wrong, I am not normally a fan of convertible deals / warrant issuance in general but these Biotechs are kinda in a different realm IMO because they can get bought out SO FAST..... I have gotten impatient before and missed the big ride on these.... I’m strapped in. Lol.
GLTYA $RLFTF
Yes sexy NEWS here, and chimes back to the Aug. 31 PR ...... So now they have like $52mln USD to work with here .... I like the tune of this:
“Funds raised amount to CHF 17,949,600. The available cash on the balance sheet of the Company, after receipt of the funds, will be approximately CHF 48,000,000 and will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (IV) in COVID-19 acute respiratory distress syndrome (NCT04311697) and the RLF-100 (inhaled) trial for the treatment of non-acute lung injury in COVID-19 (NCT04360096) as well as to run a phase 3 study in Europe. Relief believes that with the conclusion of this raise, its capital resources will be sufficient to support its planned operations through 2022, without taking into account potential revenues generated from sales of RLF-100. Execution of the SSF, together with the latest exercises of stock options, will bring the total amount of shares outstanding to 2,580,068,581.”
Sept 28th: https://www.accesswire.com/608019/Relief-Announces-Capital-Increase-from-its-Final-Tranche-of-the-Share-Subscription-Facility-with-GEM
Aug 31: https://www.pharmiweb.com/press-release/2020-08-31/relief-announces-successful-up-listing-from-otc-pink-to-otcqb-and-capital-increase-from-its-share-su
From the 31st:
“As part of the Company's growth and evolution strategy, Relief successfully met all qualifications to up-list from OTC Pink to OTCQB. This will allow a broader range of investors to invest in Relief Stock. The OTCQB is operated by the OTC Markets Group, Inc. and is designed for early-stage and developing companies located both in the United States and abroad. To be eligible for quotation on the OTCQB, companies must be current in their reporting and undergo an annual verification and management certification process. Companies must also meet a minimum bid price test and be solvent. The OTCQB is recognized by the Securities and Exchange Commission as an established public market and provides current public information to investors that need to analyze, value, and trade securities. Relief intends to seek a future presence on a regulated exchange such as the NASDAQ or NYSE MKT.
In addition, Relief raised funds from the Share Subscription Facility bringing the total amount of shares outstanding to 2,534,168,581. As of August 31, 2020, Relief has an available cash balance of approximately CHF 32,000,000, which will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (Aviptadil) in COVID-19 acute respiratory distress syndrome (NCT04311697) as well as to run a phase 3 study in Europe.”
$RLFTF
I agree and that’s why I am here !! Weee
Absolutely! Enjoy your weekend everyone
So close. Always CFGN up there with his fuckery. Looking good for next week though ! $WUHN ! Long slug outta Wuhan, as we knew LOL
Me too ... but I don’t like ‘em any older than that ! ;)))
Ready to see those .50s and .60s
Gotta be something big next week with this Friday EoD volume I’d think?? Just speculating....maybe all our collective Wuhan rage just spilled out into buying. Hahaha! $WUHN
Yeah you can either be buying that crap now after all the Series A & B offerings & Expression of Interest....... and then LOSE YOUR SHIRT.
OR do some DD & grab M2BIO ground floor. That’s the way I see it, and I waited almost 2 years for the CMPS IPO.
$WUHN
Here’s our .60
Couldn’t have said it better!