MSB Trading 2020 - a new dawn, page-9464

Hi ddwn,
I've had the same thoughts, so a few pages back in this thread I posted this: https://hotcopper.com.au/posts/48357423/single

I think you're on the money with "the FDA flipped and changed their mind late in the BLA process."
The political flavour of the time, job protection, arse covering, pharma, etc etc all seems to point to SI being led up the garden path.

The heading literally stated that the FDA was defining what was essential under Trump's 'Buy American' executive order.
Bell Porter's description after the CRL stated it was a political decision.

2 lines that stood out for me were:
""FDA commissioner Stephen Hahn has several more tasks on his list.Working with HHS Secretary Alex Azar, he’s charged with accelerating FDA approval for domestic producers""
For its part, the White House insists that lowering the regulatory barrier to domestic pharmaceutical manufacturing (and perhaps raising the bar for foreign players)

My summing up:
The date of the above was August 6th, so well before our sr-GvHD decision - no doubt the political landscape had changed so FDA had little choice but to employ delaying tactic. ie shifting goal posts.
So,: Roll on election day and then we may see FDA guidelines change to a level playing field if a different administration is in the whitehouse.
The current head of FDA has cow-towed to DT's wishes by authorising use of the failed Hydrachloroquinine and now Remdisivir. Both of which have been proven by the WHO as having a higher mortality rate than a placebo group!! Yet a treatment with proven efficacy like Remestemcel is delayed/knocked back for use by dying kids.
One can only think its purely political, and decisions made to save their own jobs.

I think all the way through the process, SI has listenned intently and been guided by the FDA, only to be shafted at the last minute.
Never-the-less, it will only be a blip on the radar in a few months.
This road has been bumpy for nearly a decade and a half, and there's still probably a pothole or two in front of us.
BUT, I feel the winds of change blowing.......there IS good things not far away of that I am sure!
I havent held for this long just to give away the game now.
GLTAH and go SI and team.
DYOR