By focusing on trial start time I think you are focusing on something that has no inherent value. And if management slips a deadline (to the extent the end of year was a created expectation by them) I think you'd be mistaken if you think shareholders are going to be surprised about that.
It doesn't matter when the trial starts (in my opinion) it matter when it finishes (or when some scientifically meaningful further results become known). It would be better not to start this year then to start this year without having a good basis for confidence that recruitment can be done in a timely manner. It also could be better to never start if there is never a good chance of a successful finish. A successful finish will depend on estimating recruiting rates from centers in different countries - yes presumably the US will be a significant part of that - but forecasting, in my opinion, should also consider whether centres will be able to get patients to accept a protocol where a third of them will get standard of care only - which is like a commitment to no other experimental therapies. Personally I found it a bit persuasive that experts not directly related to MSB (ie other than Joanne Kurtzberg) also gave evidence that recruiting in Europe for GvHD had been difficult - indeed caused a trial to not go ahead, because patients or doctors of patients wouldn't accept the chances of patients getting in the control arm.
From comments at the AGM its clear that the company is being more careful about recruitment planning than they were with MEND. Will they be careful enough - I don't know. For the most part shareholders are kept in the dark on details.
To answer your question on likelihood, one would nearly need to do the planning exercise I hope the company is doing. I.e contact centres that have historically treated patients for cancers etc and so have had streams of people getting GvHD and talk to them about historical rates and about the chances of the protocol being recruited into with the control arm.
Alternatively you could ring/email the company and ask.
CYP Price at posting:
33.5¢ Sentiment: Hold Disclosure: Held
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