Ann: Update on BLA for Graft Versus Host Disease, page-235

The issue is this approval was supposed to be a "gimme" so to speak. Our other future potential approvals are much less likely. This is the one that had everything on its side.
9-1 ODAC vote
Strong overwhelming efficacy
Absolute safety profile zero advertise effects
NO ALTERNATIVE treatment (thats the big gold star right there)

And these donkeys still said no and have asked for more trials.....which introduces the possibility that those trials take time (cash is still burning) and that the extra trial MIGHT fail.

Then there are all the other trials like CHF and ARDS etc that are in the "less likely" to be approved category that still factor into the MSB price and must now be discounted even further if this trial was given a reject.

Long story short I recall very specifically posters like Ecoool and others stating that the $3.00 range was supported by GVHD sales alone that even if no other trial was approved GVHD alone would see MSB being a 3-4 dollar valuation company off those sales.

Now that premise no longer exists and a dark cloud is cast over everything and I mean a VERY dark cloud. And the big one nobody has mentioned but me is another CR now absolutely must occur and it will occur in very market poor circumstances.
We will see $1.00 range again in my view.

For the holder who continue to hold I HOPE NOT thought but I think it will as we were at 1.00 valuation range before and we were in a better position than this at the time. Now we have actually been rejected.