One can get depressed by the fda actions and I do as I have ,through years of experience , found the fda to be on the the one hand a great force for good and yet on the other hand the biggest bunch of hypocrites I have ever encountered. Clearly the odac committee meeting underlined this when the most vociferous opponent of remistemcel was massively conflicted. Hey ho !!
but let us not lose the facts that, as silviu has said , ards is a 100times bigger market than gvhd and I sadly do wonder if gvhd will ever be approved as it makes no economic sense . Secondly if you watched any of the TV coverage the commentators kept mentioning that the response to the remistemcel infusion was rapid . They did not have to say that but they did . We kind of ignore lower back pain but it is a monster market and funnily enough might also open up the market for other joints like knees and hips ( wishful thinking ). Thirdly the lower back pain thing is for real . It is ahuge unmet need and grunenthal , before they invested, looked at a huge amount of data that we are not privy to. But thinking clbp through , in the phase 2 trial they were probably quite liberal in their recruitment. But when you move into phase 3 you are laser focused on the type of patient you recruit and thus you would have thought you recruit more appropriate patients to prove the hypothesis . That is what is going on with the covid 19 programme . They are clearly recruiting those that are at the end of the road to make a difference . The same is true in the heart trial where there is a truly. . massive runway to go for . Clearly we get depressed by all that is going on but I have to say the old blast has huge long term. Upside .
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