The fact is that the FDA is new to the world of stem cells and the guidance they gave was onerous and unnecessary requiring a standard of proof out of proportion to the context of the issues involved.
The real experts in the room are SI and his cohorts who in fact led the FDA to how to approach the whole issue of eliminating the backyard operators and bringing in accountability and proof.
But this is with the intention of making the technology widely available through the hospital system and not just limited to the cashed-up few going to exclusive little autologic operations.
The fact the FDA is prepared to risk lives and effectively sacrifice them, albeit adult ones who are without other treatment options is beyond the pale and an outrage. This is a hair splitting exercise and SI and MSB believed a more direct route can be made to achieve the equivalent in the proof of efficacy. This avoids unnecessary deaths from randomised blind trials. New parameters were obtained and then the FDA issues more?
This stinks and it's my bet the academic world is poised to give the FDA a thorough work out on this, once the dust has settled and if the FDA does not come to the party on the clarification of parameters in the trial recruitment etc. The MSB lawyers are in the background ready to strike again and the company apparently has the backing of its partners in the academic world.
This is not finished. And MSB is NOT on the brink of bankruptcy that's bandied around far too easily.
The fact is that the FDA waves through dodgy pharmaceutical drugs on a regular basis. This cannot be dismissed as only a 1% probability, any decent risk analysis will show otherwise. The data shows otherwise.
The main barrier is simply because this is stem cells and egos are involved since MSB dared push back.Quite rightly, MSB went to appeal over the BLA and will do it again if needed. If you listen closely to the corporate conference you will hear real determination in SI's voice tinged I suspect with some quiet outrage.
IMO someone in the FDA has been made to look foolish, and they're prepared to sacrifice human lives to make their little technical points and recover ground to look like they are setting the agenda. The real experts are SI and team, these guys are just pretenders.
Buying more MSB on Monday.
It's particularly galling seeing LT holders of MSB capitulate with emotion and issue apologies to the most egregious of downrampers.
It's like the Nasdaq listing all over again. When even the most careful and logical posters started emoting.
STAY CALM people!
A former raider for Robert Holmes à Court told me: never make a decision based on emotion.
That's a buy or a sell. Great advice!
PS I've been distracted by several issues so dropped the ball on Friday on this. I should have started a separate thread calling for calm. I will still do it if nobody else does. The egos involved are outrageous. Now the medical technical experts are saying MSB is in the wrong. AS IF. Look at the context. This is hair splitting. Egos involved here on many sides.
MSB Price at posting:
47.0¢ Sentiment: Buy Disclosure: Held
(20min delay)