CEO interview Organicell website In the last couple of years, we started collecting a lot of data. We started filing what’s called INDs — investigational new drug applications — with the FDA to do trials for COPD and osteoarthritis.
In November 2019, before the virus hit, we started doing various preclinical studies, in animal models, to establish the therapeutic potential of our lead products for the treatment of lung diseases. And we discovered that the exosome component of our therapy leads to significant improvement in lung structure. We’re continuing those studies right now.
So upon the onset of COVID in the U.S., we had hundreds of pages of preclinical and translational data that we compiled into
an IND for submission to the FDA as a request to begin clinical trials for COVID-19. Something to keep in mind is that our company is very small relative to the big players, including Merck or Pfizer, for example. The FDA within about 30 to 40 days, provides their approval for our company to complete the first randomized, double-blinded study — clinical trial — for a product such as ours to treat lung impacts from COVID-19. That trial is continuing today.
In addition to that, we applied for single-patient emergency/compassionate use INDs, which are approved for a single patient by request of the treating physician to aid in a patient’s recovery from the COVID-19 infection.
For Organicell, this experience has been one of the most exciting and important things that we have completed in our clinical development. To start, we treated three severely ill patients with COVID-19 at Landmark Hospital’s ICU. These patients had exhausted all other medical options and were offered the right to try our therapeutic. Over a short period of time, these patients all significantly improved and were discharged from the hospital. Most of their complications resulting from the virus were resolved.
We subsequently asked the FDA if we could treat some outpatients to try to help lessen the health care worker burden in the hospitals. We treated several COVID outpatients with our therapeutic, and their conditions resolved usually within less than eight days.
Then, there was one other group of patients called “long-haulers.” The long-haulers are a population of patients that cleared the virus infection but, after months, are still experiencing debilitating post-COVID-19 complications, such as shortness of breath, fatigue, palpitations and mental fog. We treated these long-haulers, all of whom have improved their symptoms and are going back to their daily lives.
Ideally, the aim is to develop a therapeutic that works for all classifications of these COVID patients, from initial onset in the early stages to the prevention of further escalation to intubation or an ICU stage. We are currently in the beginning stages of our placebo-controlled clinical trials, which we think will be an exciting development.
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