Back pain stem cell injection, page-87

"doesn't past muster, I'm afraid"

Ok Madam thats cool. There is no question the perceived strategy to bring some 12 application on to market simultaneously from say late 2018 onwards ( to say to year 2026) was too ambitious and this resulted in the Tier 1 / Tier 2 split. When CEPH bought in, it gave MSB the opportunity to develop all applications , where as in hindsight DDD/RA/CHF should have been prioritised. Its also unchartered waters for the FDA which we witnessed when the HF MACE trial was reduced from 1700 ..to 1100 ..to 600 patients (+ potential confirmatory's).

With this in mind , if the applications had no chance of efficacy ( as you put in BMT's case ) - with new age science, there is no way the FDA would have approved any P3 trial ( it would have stopped at P2).However I cannot say with confidence that the P3 trial would of succeeded ..that would be me being arrogant, silly and disrespectful to the FDA.

I think its just as true - that you cannot say that the MBT trials are a flop and could never make it to commercialization ( now your going to tell me technically you have not said this). Don't mix up a change in strategy , with Scientific efficacy or not . You make your perceptions, with no evidence about where the P3 trial was at ? and how the FDA "in their mind" perceived the P2 data. The fact is they approved the start of P3 trial.
On change in strategy, the pivotal point (based on my research) , was the Sept 2013 acquisition of Osiris(up to $100m my recollection). This resulted in Meso needing to prioritise what applications go into Tier 1 and what is Tier 2.

Based on the approval of TEMCELL and the recent exchange transaction in JCR Pharma b/w GSK and Medipal Holdings ( whose largest shareholder in Takeda) ..its now becoming clear that MSB made the right choice in putting aGVHD in Tier 1 . As Stockdog recently posted - TEMCELL will, moving forward be available in 200 Japan locations (up from 20).

Furthermore aGVHD has received fast track status in the US , the futility the test was passed in Nov 2016 and the 60 patient open label trial is coming to completion.

Finally - my sincere appreciation to the Hotman for unashamedly having the decency of confirming he is a shorter. It would be appropriate if others did the same (excluding Atiske). It doesn't change anything , just a little bit of decency on the forum.

Have a good day all.