The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )

KING WILL

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Vascepa Covid 19 Amarin IR Response from tcanoy on IHUB
IR Response to EPA/Covid 19/KD Pharma question....I sent the email below

As we stated on the April 13th call,
We, together with leading physicians on multiple continents of the world, are reviewing whether there are opportunities for Vascepa to be used in acute or chronic settings to potentially mitigate heightened cardiovascular risks associated with COVID-19.

That is all I can say at this point in time.
Thank you,
Elisabeth

Where is Amarin on this.....only that we are in the drivers seat.....what are we waiting for? We have a blockbuster FDA approved drug and here we sit watching from the sidelines while other companies are making the effort on Covid 19 possibilities....I just DONT get it

04.16.20
KD Pharma and its partner, SLA Pharma, have announced that its new drug candidate, EPAspire, will be used in clinical trials as a possible candidate to treat patients with COVID-19 symptoms. The MHRA in the U.K. has approved the trial nad late-stage discussions are going on with authorities in other European countries, and an application has been submitted to the U.S. Food and Drug Administration (FDA).

EPAspire’s main active ingredients are EPA free fatty acids and a sweet wormwood extract.

“We hope EPAspire will be able to reduce the risk of coronavirus complications progressing to serious outcomes like ARDS (Acute Respiratory Distress Syndrome), the need for artificial ventilation, and intensive care,” Oscar Goet, KD Pharma CEO. “This unique preparation has potential, to not only modify the COVID-19 disease process, reducing harmful, excess inflammatory responses, but to do so without suppressing the immune response to the virus which is cvital to seroconversion giving the patient ongoing protection against continued viral challenge.”

SLA reports that it is “leading the clinical development to expedite the trials in various countries working closely with the respective regulatory authorities,” SLA CEO Justin Slagel said.

Eligible patients with a positive COCVID-19 test result will be able to participate in the trial, and, after enrollment, will be givent the product within a day of hospitalization and continue treatment for one month with a two-week follow up. They will be monitored for progression to more serious outcomes and markers of inflammation, with the aim that EPAspire could help reduce the risk of mortality in severely ill patients.

EPAspire is a unique, novel formulation of highly purified EPA free fatty acid in gastro-resistant capsules which deliver it to the gut at optimal pH to allow for maximal absorption. EPAspire is currently in a clinical trial in Europe for the treatment of familial adenomatous polyposis (FAP). Proprietary data from the FAP trials suggests that it suppresses expression of inflammatory cytokines believed to contribute to the progression of COVID-19 symptoms. Since the drug is currently in a Phase 3 trial for FAP in multiple countries, the companies have been able to initiate the COVID-19 trials very rapidly. The safety profile of EPAspire is well established from previous clinical studies.

The primary investigators in Italy who designed the protocol believe EPA-FFA may change the course of COVID-19 by modulating immune response and protecting patients from its most severe complications.

“EPA is a free fatty acid that is very promptly absorbed and incorporated into the body’s phospholipid membranes, and then starts to act very quickly,” the investigators wrote. “Once incorporated into cell membranes, EPA-FFA significantly affefcts the production of pro-inflammatory mediators such as IL-6 and leukotriene B4 that play a crucial role in starting and maintaining the inflammatory process in the lungs. Moreover, EPA-FFA metabolism generates pro-resolving mediators and bioactive metabolites that enhance innate microbial killing and organ protection.”
 

GunRanger

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Been buying more and more of CRMD lately. Like I've said before there isn't that much to report on unless they drop a meaningful PR.

I think what's going on will ultimately make the CRMD investment even better. We prevent infectious diseases, something that is in the public eye more than ever now and I also believe we will get approved earlier than expected because it's a critical need right now. All signs lead to approval second half of this year and in a down market investors like to pile into winners so as always I'm still long and still taking a huge bet on Cormedix.
I added another 18 yesterday. I need to up it soon because my avg cost is still too high at $5.57
 
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