The UK mutant Virus is coming - We need the FDA to accelerate itself.

   

Situation Room Talk

  

So the C19 virus has mutated and surfaced in the UK that may be twice as catchy than the original version.  Is it here in the US yet?  Probably and, if not, it will be. Just over the weekend, we see unprecedented shut downs in the UK.

 

It would seem logical that the 2nd tier companies that some may represent better next generation treatments would be ramped up to address the threat.  Will that happen?  Call me jaded but "FDA process" to determine safety and effectiveness does not often get circumvented. But we do see Emergency Use Authorization (EUA).  Indeed, the Pfizer and Moderna vaccines are being released as approval under EUA status.

 

Vaxart (VXRT)

The UK rapid infection strain is probably already here in the US.  It means serious lock downs are coming.
 

Solution? 

The Vaxart VXA-CoV2-1 Oral Pill  will likely be proven Phase 1 safe in my view and soon.  The hamsters on the pill did much better than the control arm.  There may be pressure coming for the FDA to allow use of empirical effectivness data to EUA  to every US citizen that wants an easy pill to take at home.  Will the FDA respond like that?  doubtful.

But Vaxart should get the message out that they can do that and have the public and news media pound tables to make it happen. If they can't succeed in the US, other countries may scramble for Vaxart's Oral vaccine pill that transports and stores and is easy to swallow.

 

Some say since it uses the mucus system of the small bowel to launch protection that it could be even MORE effective that shots. This is postulated because C19 most often uses viral droplets to invade the mucus system.

Sorrento (SRNE) :  As the UK mutant takes hold,  infections will increase at an alarming rate.  Many, many people will catch C19 and the mutant forms well into 2021 and beyond.   Sorrento (SRNE) is covering the bases in developing novel testing and antibody treatments on the table of development in early clinical trails.

Sorrento's C19 antibodies are basically one or two doses in easily administered shots, not long intravenous sessions like what Trump got at Walter Reed.  And then there is Covi-Drops, the newly announced nasal drops that a doctor could possibly prescribe for at-home treatment and protection.  The public needs these at home treatments ASAP.  The human trial should be accelerated and safety and efficacy determined faster than normal FDA due process in this pandemic growing worse not better

 Inovio Pharmaceuticals (INO) uses the genetic code of a dangerous virus to quickly create a DNA based vaccine to help the immune system recognize the pathogen and in turn create messenger RNA to launch targeted antibody and T cells to provide immunity.   The INO4800 is in a Phase 2 trial.  If C19 and its mutants appear on the scene much faster than anticipated, could  Inovio's vaccine be accelerated through the process?  Perhaps not in the US.  However, other countries with large populations may decide that Inovio's vaccine safety and efficacy profile in other similar SARS epidemics such as MERS and the trial data of Phase 1 and ongoing Phase 2 is sufficient, weighing the need to save life.

There could be a push to EUA Inovio's INO4800 in countries in need outside the US that have a difficult time deploying cold storage vaccines from the two  m RNA vaccines.

Conclusion:

The above highlights areas that should be accelerated in my view. Will they? I won't hold my breath waiting on this speculation and won't bet on it in a large way.  But holding "some" shares of each of the above for the long game. Any of the above companies are buyout candidates as well. 

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ALL in my humble opinion, scroll down and read more.. 

This site does NOT make Buy / Sell recommendations.
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