CYP Price Target post MSB FDA approval., page-96

For a person that expects the world to provide hard detailed facts, you sure do like assumptions when shooting from the hip, yourself.

"I was confident that Trump appointees wouldn't get involved before the pdufa date and I was also confident that a BLA ought not be given on the basis of the science (also frankly on the basis of Silviu's character and track record I thought he ought not be trusted to do validation studies to prove up potency assays and other things afterwards - I didn't think the FDA could police him closely enough to safeguard the financial incentives he'd have to ship product that might only sometimes be potent so long as it wasn't actually harmful)".

You have a very high expectation of everyone else. Yet you run on many assumptions as fact. Regardless of your immense research, most of that above is (hindsight, but I'll let that go) licking your finger and sticking it in the air.

Of all the people and players in this game, I've always (as far as I can recall, as I do like to shoot from the hip myself - the difference is that I am fully aware of it), Dr. Eric Rose has always been a straight shooter and I believe he's the person you get if you're through messing around and you want something done right (look at his career - it is impressive - and he's earnt his reputation, IMO). Have a listen to him outlining how the last 70 or so FDA questions and subsequent communications went in the last months prior to approval, in the latest webinar with SI and the new guy, Marcelo.



Rose and Itescu were there. From their answers there are still unknowns and Rose mentions in the last months both the FDA and Mesoblast were wrong in there process discoveries (that led to an approval). They are telling us how things are but you know better? When they don't have answers to all things?

How were you going to find research when it's being discovered as part of the FDA approval process.

Why you aren't buying Mesoblast shares now that they have proven MSC's with FDA approval is your own business. It does reflect on who you are and what you are about though.


"I was confident that Trump appointees wouldn't get involved before the pdufa date" yet when SI was asked how/why the approval was given 3 weeks early he said 'I don't know'. You knew but he didn't/doesn't. Sure.