MSB Trading - 2019, page-609

Vinn,
People should remember that this organisation is not the FDA. The fact that some “efficacy” on ischemic patients has been found , clearly demonstrates a positive read through to the 65 % Ischemic populated phase 3 Revascor trial. Let is not forget it was the LVAD devices in both patient groups which were faulty which resulted in the inconclusive result. This had nothing to do with Mesoblast. The wording used in this article suggests to me ,that this will be another independently funded trial. This time it will focus specifically on our preferred patient category and implies Mesoblast will not have to make any financial contribution ( like the last trial).
I believe this to be very significant because the FDA is growing wary of giving pharma companies Fastrack approval . This is because some biotechs have pledged to undertake confirmatory tests once they have been given conditional marketing approval under RMAT designation and have then failed to properly carry out their obligations.
Mesoblast may have achieved the best of both worlds with this MOU. They will now be able to credibly represent to the FDA that an eminently respectable cardiac research body (with more than 45 centres around the US) will independently fund a confirmatory trial. MSB have always guided the market in recent conference calls that they would almost certainly require a confirmatory trial to gain marketing approval .... and MSB WILL NOT NOW HAVE TO PAY FOR IT , because it is independently funded research !!! Furthermore, when MSB have their meeting with the FDA in the next quarter they should have already dealt with the most important issue which might have otherwise caused a delay. If my conjecture is proven correct the shares will appreciate as conditional marketing approval may now be granted WAY AHEAD of timelines previously guided to analysts.
I think Mesoblast has maintained a low key stance and has not provided any explanatory notes because they are recognisant of the etiquette of FDA submissions and are wary of being seen to prejudge any issues which might be raised by the regulator. That is common sense. Nothing is done until the FDA says it is done ... but this is highly encouraging. I would expect any decent analyst should opine on the subject shortly and this should reassure the market accordingly. I bought more shares today. The upside is mouth watering.