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Brief Summary:
Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor.
Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization.
Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download
Condition or disease Intervention/treatment
Critical COVID-19 With Respiratory Failure
Drug: RLF-100 (aviptadil)
Show Show detailed description
Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
See clinical trials of the intervention/treatment in this expanded access record.
Official Title: RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol
Resource links provided by the National Library of Medicine
U.S. FDA: Expanded Access (Compassionate Use)
U.S. FDA Resources
Interventions
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Intervention Details:
Drug: RLF-100 (aviptadil)
Patients will be treated with 12 hour infusions of RLF-100 at ascending doses of 50/100/150 pmol/kg/hr on 3 successive days
Eligibility Criteria
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 12 Years to 100 Years (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Criteria
Inclusion Criteria:
Critical COVID-19 with Respiratory Failure
Exclusion Criteria:
Patients who are eligible for enrollment in RLF-100_001 are excluded from this protocol and live within 50 miles of a study site for NCT04311697 cannot be enrolled unless already admitted to an ICU and ineligible for transfer
Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
Irreversible condition (other than COVID-19) with projected fatal course
ECMO
Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);
Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
Liquid Diarrhea more than 3x/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation
Contacts and Locations
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453839
Contacts
Contact: Robert E Besthof, MIM +14842546135 expandedaccess@neurorxpharma.com
Locations
United States, California
University of California - Irvine Available
Irvine, California, United States, 92697
Contact: Richard Lee, MD richaral@hs.uci.edu
Principal Investigator: Richard Lee, MD
United States, Florida
Miller School of Medicine / University of Miami Medical Center Available
Miami, Florida, United States, 33136
Contact: Dushyantha Jayaweera, MD DJayawee@med.miami.edu
Principal Investigator: Dushyanatha Jayaweera, MD
Sub-Investigator: Daniel H Kett, MD
Sub-Investigator: Daniel D Yeh, MD
United States, Kentucky
University of Louisville Available
Louisville, Kentucky, United States, 40202
Contact: Rainer Lenhardt, MD 502-562-3000 rainer.lenhardt@louisville.edu
Principal Investigator: Rainer Lenhardt, MD
United States, Texas
Houston Methodist Hospital Available
Houston, Texas, United States, 77030
Contact: Jihad Georges Youssef, MD 713-441-3948 jgyoussef@houstonmethodist.org
Principal Investigator: Jihad Georges Youssef, MD
Sponsors and Collaborators
NeuroRx, Inc.
Cavendish Impact Foundation
Investigators
Study Chair: Jonathan C Javitt, MD, MPH NeuroRx, Inc.
Study Documents (Full-Text)
Documents provided by NeuroRx, Inc.:
Study Protocol and Informed Consent Form [PDF] July 27, 2020
More Information
Go to sections
Additional Information:
Javitt: Vasoactive Intestinal Peptide treats Respiratory Failure in COVID-19 by rescuing the Alveolar Type II cell This link exits the ClinicalTrials.gov site
Responsible Party: NeuroRx, Inc.
ClinicalTrials.gov Identifier: NCT04453839 History of Changes
Other Study ID Numbers: RLF-100_EA-1
First Posted: July 1, 2020 Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
quit stacking the ask yall ... damn!! lol
LOL Right.... you keep selling and they have no problem letting it slide down.... but the second it stops... big bids will pop up and raise it back to .0015 easy!!! then the push to .002!!
Naw just profit takers!! Some stack their shares on the ask to sell.... Some sell right into the bid after it spends 20 mins moving up!!! Stair steppin up right now tho!!! Got .0002s this morning!!
EWLL @ .0008!!!! Running!!!
NHMD .0006 Getting started!!! Shares are thin on this one!!!
SAML XSNX Moving!!!
$EWLL MOVING!!!! .0004 @@@@@ WOW!!
Exciting times!!! Expect a gap and run tomorrow !! $1 Dollar dayz coming!!!
Where you at today!! You didnt sell early did ya? I got most out @ .005 movement was crazy to me!! two days in a row the morning have been like this!! Still got a small position ( set to sell @ .0075)
$XSNX .0006 ON the edge of breakout now!!! Get those lottos before there gone!! trips will be gone today!!!
$XSNX .0006 Next one to take off from trips!!! Get you tickets!!! $$$$
$XSNX Pink Current .0005 !! 150 mil bid @ .0004 !!! less than 1 mil @ 5
$HPTY
Bid/Ask
0.005 / 0.0051
B/A Size
11,445,200 X 5,173,100
Volume
127,109,313
INSAne Breakout here!!!
bid now 17 mil!!!!
$HPTY Exploding!!!
Ride the wave.... I dunno.... but somethings up!! 50 bil AS stocks dont move like this..... All those shares are locked up!!! and re-domicile ... MONEY!!! HPTY$$$
$HPTY BEAST mode today!!!! WOW
USA markets had there 25-30% drop already and the Swiss markets have been green for 4-5 straight days.... This is their red day!! We already had ours!!! $1 dollar days are coming!!
$HPTY Another thing is this share exchange, they are all restricted shares, so they couldnt sell em for at least a year IMO.... Re-domicile From CA to USA !! AXXA/ TLNUF run coming hopefully!!!
theres an artist at work trying to paint this over .002
Should close above .70!!! Tomorrow we fly!!!!
MMs playing their games on this one!! Now a game of whos gonna get scared out!! Somethings gonna be in the works.... Ill be looking for something to be filed this week!
Quickest 10 bagger Ive had in a while!!... .0025 to .025! Gaxy insane run!!! Still got bunch of free shares!!!
Moving from Canada to California(USA) re-domicile? New President and CFO ... things are looking up it seems like!! with movement and such... it had to be retiring of shares.... the prolly retired all the existing CFO and presidents shares and maybe reduced the AS and Float!!
Swiss opened at 76 cents! 80 was their high... 96 was ours!! and we normally are a lil ahead of them in price.... so I see green today!!! :) good time to be in this stock!!
Hope all the weak hands get out before close!! Cause Monday we open higher and these prices will be gone!!!
New high coming within next hour to 1 and 30 mins!! $dollarland
where do these 7 mil stacks on the ask @ 7 keep coming from when it keeps getting bought!! What, they pull some extra shares out the closest or something?
Possible side effects..... A Woody!
$RLFTF
Congrats to All who got in and stayed in for the run!! Nice Money maker here!!!
With stocks like this, there really is no cap to how high it could go cause we've never been in a situation like this..
Look at the company that making the vaccine for Covid.... was around 5 - 10 in march.... now way over 250 and still going!... All these other stocks are posting new career highs in price!! Gold / silver shooting up like crazy!!!
Good luck to all here! $$$
$RFLTF
HUGE!!!
The first report of rapid recovery under emergency use was posted by doctors from Houston Methodist Hospital, the companies said in a joint statement.
It said a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant came off a ventilator within four days of treatment with RLF-100.
Similar results were subsequently seen in more than 15 patients treated under emergency use, the companies said.
The two companies also said independent researchers in a biocontainment laboratory in Brazil reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and immune cells.
you knows its a bunch of losers trying to short this down, that and weak hands getting scared out!!
We get volume like yesterday and them shorties will be sorry they tried this one!!! Stock that has big upswings is gonna have big down swings also... Key is keeping momentum and gaining accumulation.. Accumulation went straight down this morning!! but yea, who knows with these things... ppl are killing the momo tho..
Their walking it down!! huge bids @ .20 and .19 .... over 500k shares.... and they both got destroyed fast!!
.31 by close? Lets get there!! .50 tomorrow!!
News!
RECENT DEVELOPMENTS
Pharmaceutical Trials and COVID-19
Phase 1 (Australia) Trials
The Corporation announced on March 9, 2020, that it received approval from the Ethics Committee of the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria, Australia, to initiate a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ultramicronized-PEA in normal healthy volunteers (the "Alfred Hospital Phase 1 Trials"). The principal researcher of this first-in-human safety and tolerability study is the Chief Medical Officer of Nucleus Network, one of Australia's largest and most experienced Phase 1 clinical research organizations. Studies are being completed in accordance with FDA-approved guidelines.
The Corporation anticipates completion of the Phase 1 clinical trials to secure an IND and, assuming that the results of the Phase 1 clinical trials are within acceptable ranges, to proceed to Phase 2 clinical trials as early as the fourth quarter of 2020.
On June 22, 2020, the Corporation announced favourable top-line results from the Alfred Hospital Phase 1 Trials, with no significant safety concerns found up to the highest dose tested of 2400 mg/day. The Alfred Hospital Phase 1 Trials were a single-site study and were conducted at the Alfred Hospital with 48 healthy adult men and women enrolled. The trial sequentially tested single ascending doses ranging from 600 mg to 2400 mg tablets and multiple ascending doses ranging from 600 mg to 1200 mg tablets administered twice daily for 7 consecutive days. The single ascending dose subjects also were tested for food effect.
The study found FSD-201 to be safe and well-tolerated. Mild and self-limiting side effects were reported and were deemed unlikely to be related to the drug being studied. There were no abnormal laboratory findings or electrocardiograms observed during the study and no serious adverse events were reported. No subjects withdrew due to an adverse event and all eligible subjects completed all doses. The pharmacokinetic profile of FSD-201 utilized in the Alfred Hospital Phase 1 Trials is still being analyzed. The results of the Alfred Hospital Phase 1 Trials are subject to additional audit and verification procedures. See "Risk Factors - Interim, "top-line," and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data."
FSD-201 COVID-19 Trials
On June 3, 2020, the Corporation announced that the FDA has given the Corporation permission to submit an IND application to design a Phase 2(a) clinical trial for the use of FSD-201 to treat suspected or confirmed cases of COVID-19, the disease caused by the SARS-CoV-2 virus (the "FSD-201 COVID-19 Trials" and, together with the Alfred Hospital Phase 1 Trials, the "FSD-201 Trials"). Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. The Corporation is focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
Based on FDA feedback, the Corporation anticipates the FSD-201 COVID-19 Trials will be randomized, controlled, double-blind, U.S.-multicenter study to assess the efficacy and safety of FSD-201 dosed at 600mg or 1200mg twice-daily, as well as potentially higher dosage levels, together with standard of care ("SOC") compared to SOC alone in symptomatic patients with clinical presentation compatible with COVID-19. Eligible patients will present with symptoms consistent with influenza/coronavirus signs (fever, dry cough, malaise, difficulty breathing) and/or newly documented positive COVID-19 disease.
The primary objective of the FSD-201 COVID-19 Trials is to determine whether FSD-201 plus SOC provides a significant improvement in the clinical status of patients (e.g., shorter time to symptom relief). Secondary objectives of the FSD-201 COVID-19 Trials include determining whether FSD-201 plus SOC demonstrates additional benefit in terms of safety, objective assessments such as length of time to normalization of fever, length of time to improvement of oxygen saturation and length of time to clinical progression, including time to mechanical ventilation or hospitalization, and length of hospital stay. The exploratory endpoint is cytokine clearance as measured by Enzyme Linked Immunosorbent Assay (ELISA). The treatment period of patients in the FSD-201 COVID-19 Trials is expected to be at least 14 days. All patients who experience clinical benefit are expected to continue to receive their assigned treatment until study completion.
S-12
The Phase 2(a) clinical trial program is subject to successful completion of the Phase 1 clinical study on healthy volunteers, a favourable toxicology study, and successful completion of ongoing laboratory studies, access to additional financing, approval by the FDA of our Phase 2(a) clinical trial design, and review by the FDA of our IND application. The duration and cost of clinical trials can vary significantly depending on multiple factors, including the enrollment rate of volunteers, country in which trials are conducted, and specific trial protocols required. The process of developing pharmaceutical products and receiving the necessary regulatory approvals for commercialization typically takes several years. Accordingly, no near-term revenues from product sales or services are expected from our ultramicronized-PEA candidate(s). The milestones described above represent customary inflection points for financing by clinical-stage biotech companies. However, there is no assurance that the Corporation will be able to achieve these clinical milestones, nor, if successful in doing so, that the Corporation will be able to access additional financing on terms or timing acceptable to the Corporation. See "Risk Factors" in this Prospectus Supplement, the Shelf Prospectus, and in the 2019 AIF.
Assuming that the Corporation's IND application to design a Phase 2(a) trial is approved, the Corporation's planned Phase 2(a) clinical trial is expected to initially focus on suspected or diagnosed cases of COVID-19. Multiple trials, targeting different medical conditions and applications (e.g. other respiratory ailments presently treated with ultramicronized-PEA as a prescribed food supplement in Europe), may ultimately be undertaken depending on results observed and available capital, subject to the requirements of the Epitech License and regulatory approvals as required. See "Risk Factors" in this Prospectus Supplement, the Shelf Prospectus, and in the 2019 AIF.
June Private Placement
On June 4, 2020, the Corporation announced that it entered into definitive agreements with certain institutional investors pertaining to the private placement (the "June Private Placement") by certain placement agents led by A.G.P./Alliance Global Partners (collectively, the "Placement Agents") of an aggregate of 1,500,000 Class B Shares at a price of C$6.75 per Class B Share and warrants (the "June Warrants") to purchase an additional 1,500,000 Class B Shares (the "June Warrant Shares") for aggregate proceeds to the Corporation of approximately C$10,125,000 (before deducting fees payable to the Placement Agents and other estimated offering expenses). The June Warrants have a five-year term and an exercise price of C$9.65 per June Warrant Share. The June Private Placement was completed on June 8, 2020, generating net proceeds to the Corporation of C$9,416,250. In addition, the Corporation granted the Placement Agents an option to arrange for purchases of up to an additional 1,500,000 Class B Shares and June Warrants to purchase an additional 1,500,000 June Warrant Shares on the same terms as the June Private Placement for a period of 30 days following the initial closing of the June Private Placement.
Equity Distribution Agreement
On July 10, 2020, the Corporation entered into an Equity Distribution Agreement with the Placement Agent pursuant to which the Corporation may, at its discretion and from time-to-time during the term of the Equity Distribution Agreement, sell, through the Placement Agent, Class B Shares of the Corporation for aggregate gross proceeds to the Corporation of up to US$20.0 million. No offers or sales of Class B Shares will be made in Canada on the CSE or other trading markets in Canada. As of July 30, 2020, the Corporation has sold an aggregate of 48,317 Class B Shares for aggregate gross proceeds of US$184,626.87.
Approval of Issuance of Share Compensation
On July 24, 2020, the board of directors of the Corporation authorized the issuance of 1,322,927 Class B Shares in the aggregate as compensation to its directors, officers and certain of its employees.
Suspension of FV Pharma Activities
On July 30, 2020, the Corporation announced that it has notified Health Canada of the Corporation's decision to forfeit the Cannabis Act licenses of its wholly owned subsidiary, FV Pharma, Inc. ("FV Pharma"), and suspend all activities by FV Pharma within 30 days of the notification date. The Corporation has begun the process of liquidating all of FV Pharma's assets, including the sale of the its cannabis production facility in Cobourg, Ontario (the "Facility") and/or the adjacent real estate.
USE OF PROCEEDS
The net proceeds to the Corporation from the Offering, after payment of the Placement Agent Fee but before deducting the expenses of the Offering (estimated to be US$375,000), will be US$9,299,996.84.
S-13
The principal business objectives that the Corporation expects to accomplish using the net proceeds from the Offering together with the Corporation's current cash resources and potentially other funding sources, are to finance future growth opportunities including acquisitions and investments, to finance our capital expenditures, for working capital purposes or for general corporate purposes. In particular, the Corporation plans to use the net proceeds from the sale of Offered Shares, if any, to continue advancement of the near-term objectives with respect to its R&D program for the commercialization of ultramicronized-PEA, being the submission of the IND application to the FDA for the FSD-201 COVID-19 Trials and the initiation of the associated Phase 2(a) clinical trials. While the Corporation is specifically working to advance the development of ultramicronized-PEA towards ultimate commercialization, it is also continuously seeking and assessing additional opportunities in the biopharmaceutical space.
Through the next 12 months, the Corporation currently expects to incur cash expenses that exceed, and may significantly exceed, the amounts described in the Shelf Prospectus under "Use of Proceeds", due to the potentially expanded scope of the FSD-201 COVID-19 Trials, as well as the accelerated timing of preparing for and completing such trials. The Corporation expects to fund such expenses from the net proceeds from the Offering, if any, together with the Corporation's current cash resources and potentially other funding sources, which may include the issuance of additional equity, equity-linked or other securities, and which may also include secured or unsecured debt financing. If the Corporation issues notes or incurs any other indebtedness, a portion of the proceeds of this Offering, if any, may be used to make interest and/or principal payments with respect to such notes or indebtedness. The completion of the FSD-201 Trials and the pursuit of the Corporation's other business objectives is subject to the Corporation obtaining sufficient funding. See "Risk Factors" in this Prospectus Supplement, the Shelf Prospectus, and in the 2019 AIF.
we goin back to at least $20 here soon!!
Mostly buys and goin down.. Nice.. tons of shorting and maybe a lil selling... Buying is steady!! just waitin for the games to stop/reverse...
This hasnt even traded yet in normal hours since news.... All after market yesterday and premarket today!! Once we open, Im thinking a steady rise! could see a 10$ /share fast! Maybe a circuit breaker or two...
HUGE also
Lots of churning in this area!! steady buying happening!
Especially for anyone who got in below $10 !! Skys the limit now when it comes to Robinhood and all these companies that let ppl buy shares with any amount of money... Lots of ppl were shorting this stock yesterday... they better hope they bought them back already or their toast.... I dont see it dropping below 26.. High Ill give it 70$
Why not? .. Their Pink Current... the pictures someone posted of google earth are the same ones on their page.... Bitcoin is virtual ... they cant be mining right there???
OS hasnt changed in 2 years.... floats been around 1.9 - 2 bil....
Thats a lot... but theres other stocks that are that high and do fine....
Might of been garbage before but its looks like their trying to turn it around.... filing say they have 55 miners( machines) just acquired more in March...
So wheres the prove of this having nothing to do with bitcoin and it being a scam?
If they won the Initial decision in Nov 2019... Why havent they been upgraded to PINK OTC... Ive seen many other random companies upgrade to PINK.. Why not DBMM , they have the fins submitted, 10-Q, K filed for past years... Is it still ongoing or is it CLOSED?
nothing filling below .0052.. Pennies next week!!