I have emailed Paul and received a response within 48 hours to...

I have emailed Paul and received a response within 48 hours to my enquiry on matters....I was comfortable with his response to a couple of queries i had.

The level of FUD that is being generated on the basis of missing the second quarter submission target is in my mind disproportionate to the range of known knowns including:

A) That the FDA have indicated that there is sufficient data to resubmit and the invitation to resubmit
B) The resulting reversion in business strategy to seek approval for Rem in aGVHD in adults once approved
C) The value accretive nature of approval, not just as it relates to aGVHD in children, but validation of the platform technology

Not suggesting that it is not annoying/frustrating, especially when folks are significantly invested and for LTHs, but two weeks is not long to wait in the overall scheme of things. I much prefer to ensure that the submission represents the most complete, well-proofed document that finally gets approved, than a submission that merely seeks to meet a second quarter deadline.

There are a range of possibilities in predicting the likelihood of meeting a deadline, that may not have been apparent at the time of making a second quarter submission forecast. I want the submission to be made as much as anyone, I just dont belive it warrants the current sell down.

GLTAH
V