My eyebrows went up a notch or two when I read about US enrollment, but regardless I did get a positive vibe from the news based on what I'll call a "tone of expectation".
I know the company is blinded to the reuslts, but this sentence jump out...
"....conduct a sample size re-estimation analysis assuring that the trial will be sufficiently powered to confirm relative risk reduction..."
The way that's worded it strikes me...its almost like they know the trial has proven signficant RRR, but they want to make sure the sample size is big enough. And then it concludes with language that is suggestive of a high degree of confidence about making a NDA.
..."We are exploring the option of US enrollment in the BETonMACE trial as well as the option of relying on existing BETonMACE data to file a US New Drug Application (NDA). It is management’s belief that the determining factor for all approvals will be based on the strength of the final BETonMACE data. We will wait until the data roll-out before updating any proposed drug registration timelines..."
Of course in the interim we need $$$ news. If NDA approval is close to being a sure thing I can't imagine finding the financing required would be any problem.