Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-603

A conspiracy theory.

Some of us, perhaps, are getting concerned about the timing of the approval of Ryoncil. At the same time, President Trump has Tweeted that he believes “deep state” forces in the Food and Drug Administration are delaying approval for treatments in order to damage his chances of re-election.

Nothing I say should be taken as a comment on US politics or the upcoming election. The whole world has a dog in that fight, but for those of us who don’t get to vote (I’m Australian), good manners and respect for the American people should prompt us to leave the choice of a person to lead them to their good sense. For a very long time the USA has been driven by an underlying sense of morality and justice that has made it, in a world more used to expediency and realpolitik, a beacon of principle and a force for good in the world. I expect that to continue.

But there is no question that politics has got increasingly partisan. It doesn’t seem to me impossible that there might be those who would regard an early approval for paediatric SR-aGVHD and extension to COvid-19 ARDS as politically undesirable. One hesitates to think that anyone would put party-politics above the lives of even a few children but people can easily persuade themselves of the rightness of something they are motivated to do, focusing perhaps on the necessity of protecting consumers from the uncertainties of manufacturing consistency, or on designing a phase 4 trial for post-approval.

In this election, even more than most, many votes are being cast early.

So, might there be an attraction in some quarters to as late a graft-versus-host approval as possible, say 30 September, and then an extension to Covid ARDS a few weeks later? Say, 4 November?

If so, that would make the present depressed SP a real buying opportunity.