@col69: Thanks for your kind words, as always. Much appreciated....

@col69: Thanks for your kind words, as always. Much appreciated.
The naysayers saying this PR is fluff and mgmt has lost credibility are of course, entitled to their opinion.
If I myself believed that mgmt has lost credibility and is putting out fluff PRs, I would definitely sell and move on. No two ways about it.
Yesterday's PR, in light of what SI has been saying about pursuing RMAT designation for several indications, is very telling in that:
1) The FDA must have surely gotten enough time by now to review MSB's RMAT applications
2) CHF is a major unmet med need and has no "cure" and hence warrants the accelerated push towards a conditional approval based on strong prelim results, while Phase 2b (end stage) and Phase 3 (advanced) CHF trials are on-going
3) the use of words "accelerated entry of this product candidate into the market" (the third bullet point does not have "potential") is very telling

I have my own interpretation of the PR, based on the timeline since the passage of 21st Century Cures Act as well as what the FDA has done granting RMAT for other companies' treatments. Those other treatments were autologous, while MSB's are allogeneic, which is probably why the FDA is taking longer to grant the RMAT designation.

Finally, those who think MNK is going to roll over obviously think they know it all.
MNK is doing many things proactively to improve their business (I don't need to repeat what the recent happenings have been). But they also are "cut-throat" in staying very, very relevant with "certain bodies" that matter. Take a read below:
https://www.nytimes.com/2017/07/21/...s-big-in-washington-to-make-itself-heard.html