@ddwn raised a great point that I think has gone very underestimated here - the involvement of NIH in this whole thing. Novartis is a for-profit company that's only looking out for its best interest. The NIH, who footed the bill for this trial, has an entirely different focus. Here is NIH's mission stateemtn:
NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to
enhance health, lengthen life, and reduce illness and disability.
The goals of the agency are:
- to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health;
- to develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease;
- to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and
- to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.
In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
- in the causes, diagnosis, prevention, and cure of human diseases;
- in the processes of human growth and development;
- in the biological effects of environmental contaminants;
- in the understanding of mental, addictive and physical disorders; and
- in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.
My guess is that the NIH's voice will be VERY, VERY loud in the FDA's ears, much louder than MSB's or Novartis' could ever be.
Keep in mind, too, that the FDA itself was involved in the design of the ARDS trial. They are very well aware of the design, and if I recall correctly, actually suggested modifications to the same early in the piece.
As well, this is one of the ONLY COVID-related trials (save for the dexamethasone trials) that has shown real efficacy. That's huge. You would imagine the Biden White House, very eager to show they are fixing Trump's catastrophic handling of the pandemic, would love to add an approval for an life-saving treatment to its list of "successes."
Finally, I found it interesting that when asked about an EUA for Rem-L in ARDS, SI was VERY muted - he gave no real answer on that and punted to Fred Grossman. Fred was a bit more bullish there, but I wouldn't be surprised if the string of mixed results from all of our Phase 3 trials and the threat of an Oz class action hasn't chastened SI & Co. a little bit, causing them to play their cards a bit closer to their chests.
(20min delay)