It's worth being mindful of what SI can say publicly and why. If the FDA has had issues it's not for SI to point that out let alone explore it.
He's the epitome of tact, sensible appropriate comments and dignity even when under fire. IMO.
The issues have been pointed out in here and they are operative IMO. No question in my mind what they are but I will not and cannot speak for SI. Just all IMO and I have a regulatory background.
The panic merchants will try to get you to hit the fear button and react. Logical calm analysis and extrapolating from that, is what's needed.
And always, always look at this with fresh eyes, no matter how jaded you may feel. Park those feelings to one side. IMO this is what's needed.
This has been done many times by analysts in here not least of all
@ecoool2 (who sadly got fed up, people know where they can find him it's another site we cannot mention but it's got a ringing echo of the stage name of an actor whose real name is Greg Gomez Pead).
It's no accident ex FDA Kraus is on our team. Longevity is indeed the key and having results that show longer survival is absolutely sensible for showing the maximal results of the cells which DO indeed work! It's about showing how WELL they work, and this is in the revised data, so take another look and let it sink in.
Think about how convincing this is likely to be to the FDA. After all, the problem has been that they are unsure how to evaluate. So how about if MSB shows them something truly impressive? How is this difficult to understand? Why would this be a waste of company time?
Also think about why MSB is so preoccupied with getting the first product to market in the aGVHD space. Children first, then adults. This is logical.
How will the rest of the products be received once the FDA gets over the first hurdle? How do you reckon, when the biggest problem is unfamiliarity?
I remember when I was a little kid afraid of riding a bicycle. Each year he'd say:
when are you going to ride the bike? And I'd put the year off,
when I'm 7 I'd say...when I'm 8 I'd say.One year he put me on the bike and pushed me down the hill.
Now there was one tree at the bottom of the hill. ONE.
Because I was so obsessed with that tree, fixated...
I rode right up to it and....
hit the bloody thing!!
I fell off the bike utterly flattened looking at the sky.
What are you fixated on?
Clearly I should have just applied the brakes and taken control of the bike. But I forgot!
Instead I was captivated by fear and it led to precisely the result I most feared.
So before you get shaken out of your shares by fear, think of me,
flattened on the ground looking up at the sky and realising I had just make a huge mistake.
I feel lucky to have learned that a valuable lesson so early.
Fear or indeed impatience, are not analytical methods. They do not have you in control. They take control.
All IMO. DYOR.
(20min delay)