“FDA PLAYING WITH FIRE"...

“FDA PLAYING WITH FIRE"

https://nbc25news.com/news/nation-w...s-to-fast-track-covid-19-vaccine-experts-warn

The article in the link, from a U.S. Fox affiliate, includes serious concerns about some recent FDA decisions and perceived White House influence in fast tracking Emergency Use Authorization for Covid-19 treatments, including hydroxychloroquine and convalescent plasma.

The author also suggests a recent statement from FDA Commissioner, Dr Stephen Hahn, that “the agency would be willing to authorize the use of a coronavirus vaccine before it completed the final phase of clinical trials”, could undermine public confidence in the FDA.

Some recent surveys suggest that 78% of Americans are “worried that the Covid-19 vaccine approval process was being driven more by politics than by science,” and “one third of Americans would refuse to get a coronavirus vaccine, even if it had gotten FDA approval and was free.”

For MSB's cell suite to gain maximum acceptance, I’d definitely prefer to see the approval process for remestemcel-l in SR-aGVHD and Covid-19 ARDs go through normal unpoliticised channels. The FDA played (very) hard ball through ODAC, and imo that will be to MSB’s long term advantage.

Given the looming election, and mounting disquiet in some sectors about the White House response to Covid-19, In my view it could be a poisoned chalice to have the President jump on the Mesoblast bandwagon?

In order to springboard from FDA approval to the EU and beyond, the process must be, and be seen to be, squeaky clean. These early approvals are the lynch pin of so much more to come, in USA and beyond.

So while like everyone I'd like a quick result, I’m happy to see the ARDs trial continue for as long as it takes to glean a strong and irrefutable data set.

https://nbc25news.com/news/nation-w...s-to-fast-track-covid-19-vaccine-experts-warn

One man’s opinion. Usual bias.

Herro