Pfizer Covid Pill: Gameover for MSB's treatment, page-21

You say: Not sure I agree there will be lots of patients to treat. By the time they have been treated with all the better cheaper alternatives, and then it is realised they did not work, it will be too late.

My response: You have no clue whatsoever.

COVID-19 and ARDS due to COVID-19 are two separate conditions and need to be treated differently.

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with the virus will recover without requiring special treatment and may only experience mild to moderate respiratory illness. However, some people can become seriously ill and require medical intervention. Those that tend to go on to require medical intervention normally include people that are at a higher risk of developing a serious illness (e.g. elderly, immunocompromised or those with underlying medical conditions like CV disease, diabetes, chronic respiratory disease, caner etc); however anyone can develop a serious illness or die at any age, including the young and healthy. Therapies such as antivirals and/or monoclonal antibodies etc may be used for at risk patients positive to COVID-19 in an attempt to stop the disease progressing into a life threatening situation.

Alternatively, ARDS due to COVID-19 is a predictable serious complication of COVID-19 which is marked by severe inflammation and serious respiratory distress. These patients usually require intubation, long ICU stays and are at high risk of death. Our therapy (Remestemcel-L) has previously shown survival benefits and reduced hospital stays for patients under the age of 65 (particularly when combined with corticosteroids) for patients that go on to develop ARDS due to COVID-19.

So medications and interventions are distinct depending on whether you have either: COVID-19 (from nil, to antivirals and/or monoclonals etc); or you have progressed along the disease pathway to develop ARDS due to COVID-19 (oxygen support, dexamethosone, and potentially soon Remestemcel-L if successful in obtaining an EUA after a positive NIH led trial).

To circle back to address your statement, because ARDS due to COVID-19 is a serious and life threatening complication of the COVID-19 infection (i.e. occurs later on in the disease progress, usually as a result of the bodies and therapies inability to bring the COVID-19 infection under control) it is therefore not too late to administer potent anti-inflammatory medications/interventions required such as Dexa and Rem-L to treat the acute respiratory distress.

And to your second point being a limited market, well I say COVID-19 treatments are not perfect and as a result a proportion of these patients will go on to develop ARDS due to COVID-19 and require oxygen supportive measures and powerful anti-inflammatories like Dexa (and Rem-L if granted an EUA). Also there will always be some patients who refuse the early intervention medications (or leave it too late) only to end up in ICU needing the help of powerful anti-inflammatory medications/interventions to save their life.

Positive words from our CEO just recently at the Edison Group Global Healthcare Conference that we will be working with our partner (NIH most likely) to do another trial to bring Rem-L to market under an EUA for the treatment of ARDS due to COVID-19 if positive results prevail. Certainly worth progressing IMO if fully funded and as no signs of COVID disappearing soon.

I would not be surprised if more details are given around the next steps (partner) for COVID-ARDS trial at or around the same time a positive OTAT meeting is announced for aGvHD (I am assuming they will announce the results of that meeting when the formal minutes are in hand).