Edesa Biotech Inc (EDSA) News

Nobody watches this stock and that's a mistake. 12 month minimum for full data analysis but we can get the interim data analysis much sooner. There was 125 patients enrolled in the Canadian P3 and that was 2 years ago. Recently, the Canadian P3 and the US P3 have been harmonized and the patient protocol has been changed to 600 total patients from the original 800. We could be closer than we think. Upon that data, the shares will double or triple, if I were Par, I would apply for EUA and the shares will rocket even further. He can then do an offering at a much higher valuation, and start the P2 Vitligo CXL-10, and EBO5 Fibrosis trials.

7.40$

Wonder what mm are doing - 35 min volatility halt is definitely longer than normal

8k out

Needs to show .84 support and then off to the races

Chop chop as high as $1.08 has a variety of resistance levels and has a phase 3 in works

EDSA: Hey, big THANKS to ya, Capt. S-L!!!

And, by the way, GO-GO-GO-EDSA=$$$$$$

Hey my brother I feel great that you are cleaning up :) Hey EDSA gained again today. Feeling a nice play in the near future .

EDSA: Hey, & YOU'RE stock picks, Sir, have been a "blessing" --- to my BANK account balances, Bro!!!

$2,26 close so that dip last week was a Godsend

Once the volume picks up, we will have a classic run., :)

EDSA: And THAT one, too!!! GO-GO-GO!!!

$2.25 and looiking up! LOL

POP @ $2.14 up 23% LMAO. :)

Dip then rip!

lol

EDSA; YEP!!! That's how the SMART players do this. (Not sure if I qualify, though.)

watching for poss re entry here.

EDSA: Hey, I hear-ya on THAT note, 'S-S' Dude!! (EDSA up a pinch, as I write this.)

Geeze dude, I hope that got prepared you don't wanna be in the middle of the Pacific ocean and have that happen EDSA is a baby for keepers

EDSA: Yep!! it sure is, Dude!!! (Sorry for this rather BELATED response, Bro!! Big BOAT issues over here in my San Diego; a LEAK!)

Is this a beautiful stock or what! 2023 will be double digs. Hope you had a nice holiday weekend bro.

EDSA: Get ready, Girl!!! X-Mass ain't over quite yet!!!

its trying, but manipulation is king for now.

EDSA: COFFEE!!! It perks-you-UP!!! I calms-you-DOWN!!! (Let's go, EDSA!!!)

this is trying to bust out in pre …

…

market but the manipulation is holding it back, for now. lets do this!

this is trying to bust out in pre …

…

market but the manipulation is holding it back, for now. lets do this!

yup, see ya in the morning!

Glad to see everyone here is making money. I've notice my post are being deleted
reena969

Re: A deleted message

Tuesday, December 20, 2022 10:22:09 AM


I missed that one Watching EDSA low float ,so many on my scanner
I loaded @.9744 .

I guess it's time for me to keep quite and just make money. Happy Trading everyone.

EDSA: See ya TUESDAY!!!

moving up eod, good sign!

EDSA: I did too, as I enjoy this OTHER 'dip'!!

EDSA: Yep!! "A beautiful ASK", indeed!!" So, SLAP-IT now, Peeps!!!

grabbed some on this dip! hi all

.$2.64 HOD :)

What a beautiful ask. @ $2.30

$EDSA : GOing over $2.20..... sheeeeeeeeshhhhhhhhhhhhhhhhh


HAPPY FESTIVUS !!!!!!!!!!!











GO $EDSA

Now she has gate speed!!!!!!!!!!!!!!!!!!!!

She is a keeper bro! :)

$EDSA: OHhhhhhhh yaaaaaaaaaa... just another GREAT DAY, now $2


How about that run, right ???


$TMNA is next


GO $EDSA

Nice!!!!!!!!!!!!!!!

$EDSA: Gettin a 2nd day boost here............


just tapped 1.30

Thats not too baddddddddddd


GO $EDSA

Been holding this one. It's got great potential and an excellent buy and hold.

$EDSA : FastTrack FDA ARDS Drug Candidate


Could get more boost today.

Now up to $1.10


GO $EDSA

Edesa Biotech announced final results from the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study. This study is evaluating the company’s monoclonal antibody candidate, EB05, as a single-dose treatment for hospitalized patients with or at risk of developing Covid-19 induced Acute Respiratory Distress Syndrome (ARDS). The company previously reported initial topline data provided by the study’s data safety monitoring board, which preemptively unblinded certain study data for efficacy signals. Edesa has now completed a formal Clinical Study Report (CSR) for U.S. regulators on the full, validated Phase 2 dataset.

Trial results: In the final Phase 2 clinical trial results, Edesa reported that EB05 demonstrated a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population). Today, the company reported a revised 28-day death rate of 7.7% in the EB05 plus standard of care (SOC) arm versus 40% in the placebo + SOC arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) or Invasive Mechanical Ventilation (IMV) plus organ support with ARDS at baseline (p=0.04). The revised Survival Analysis using Cox’s Proportional Hazard Model demonstrated that patients treated with EB05 plus SOC had an 84.0% reduction in the risk of dying when compared to placebo + SOC at 28 days.

EDSA mentioned and the company of course does not tell anything to investors.. Imo this is important and the stock will fly when the market turns or the company will put out great news

https://magazine.utoronto.ca/research-ideas/health/preventing-the-next-pandemic-emerging-and-pandemic-infections-consortium-epic/

Edesa Biotech Reports Enrollment Milestone in Phase 3 ARDS Study

TORONTO, ON / ACCESSWIRE / February 17, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on the Phase 3 part of a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose therapy for hospitalized Covid-19 patients.

Edesa reported that more than 25% of the subjects have been randomized to date under the Phase 3 protocol design approved by Health Canada. The enrollment milestone follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05's ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that as SARS-CoV2 continues to evolve and becomes endemic there's an urgent need for therapeutics, like EB05, that are agnostic to variants. "Since EB05 is designed to target the patient's own immune response rather than the virus itself, we believe it has broad potential application for Covid and beyond," he said.

"We greatly appreciate the extraordinary efforts of the clinical teams and research staff who have been supporting the EB05 study," said Dr. Nijhawan. "Based on the significant effect demonstrated in reducing mortality in the Phase 2 study, we believe that Edesa's monoclonal antibody EB05 could significantly reduce mortalities and alleviate the stress on the healthcare system, especially in the ICU where beds are limited, care is very expensive and patient outcomes have been tragically poor."

EB05 was developed to regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among Covid-19 patients. Specifically, EB05 inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that "a clinically important efficacy signal" was detected. The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa's Phase 2 study of EB05 in hospitalized Covid-19 patients was funded in part by a C$14 million grant from the Canadian Government's Strategic Innovation Fund.

The Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization's COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.

About ARDS
Acute Respiratory Distress Syndrome is the leading cause of death in Covid-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized Covid-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

https://quantisnow.com/insight/2432947?s=s

Edesa Biotech Reports Fiscal 1st Quarter 2022 Results
Monday, February 14, 2022 9:00 AM

https://www.accesswire.com/viewarticle.aspx?id=688347

new presentation

https://www.edesabiotech.com/wp-content/uploads/2022/02/EdesaBiotech-EDSA-CorporatePresentation-Feb15-2022-WEB.pdf

"Currently in discussions with the FDA on the design of the final Phase 3 protocol"

Canada is up to the challenge of Omicron (EDSA CEO mentioned)

https://www.hilltimes.com/2021/12/09/canada-is-up-to-the-challenge-of-omicron/333256