FDA have been clear about what they want BUT we are in the...

FDA have been clear about what they want BUT we are in the dangerous situation of doing a lot of work on the potency assay only for the FDA to shrug their shoulders and say they still don't like it.

All the while competitors with a big Stars and Stripes logo in their letterhead are playing catch up and maybe even getting some free back channels advise on how to avoid stepping in the same sh1t we are stepping in.

The product works, which exceeds the status of many products FDA have already approved, so it is a really frustrating state of play. People are dying, and we aren't getting income to fund the business other than a slither from Japan.

Once again, would have been nice to get a bit more clarity out of MSB, but really, we shouldn't be surprised any more!

I said it two years ago and here we go again. FDA want to see that every dose has the same amount of goodies to be sure the survivors aren't surviving on account of getting it all while some poor unfortunates aren't getting any!

Come on guys. They've shown you the bullseye. It's time to hit it!

What I'd also like to happen is that the higher ups at Surgcentre do a bit of work too. They aren't a small entity. I hope they are working whatever pressure points they can as well given how much skin they have in the game.

Hold on and hope guys. Not much else is mere mortals can do.