What a brilliant CC. It is up on the web site.
SI confirmed my opinion of the relationship between
Crohns and GVHD through ...
FECAL CALPROTECTIN
Remestemcell-L 231 - 67 @ 3 months
Controls 330 - 505 @ 3 months
That's what the Crohns trial has proven.
This trial may close sooner than expected . A pivotal trial may not need to be very large as the target population is very well defined and have very poor prognosis.
It would be a left field announcement however Takeda could have approval in Japan within 2 years . A small partnership covering just Japan would safe guard against a negative FDA going forward.
For those that have constantly blamed MSB on having the wrong primary end points, Dr Rose has confirmed that the FDA insisted that a composite of both function and pain was used as a primary end point. This was required to demonstrate safty of the application . Function was positive so safety is no longer a concern.
This is why they now will except pain only as a primary.
He also stated that the primary end point for CHF was changed by our X partner for CHF.
Talking CHF I found the conversation and time line very informative.
Good luck all.
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