Right or wrong, I have wondered if the progression from 2-a onto 2-B has gone slowly. Phase 2-a was listed in Nov 2013 and may have started dosing in 2013 December/Jan 2014. This was only for a 3 day dosing in 12 cohorts and no co-dosing was tried to the best of my knowledge, no longer dosing periods.
The wait for the 2B trial has continued while they promised that it was about to commence, but we continue to wait.
Working backwards, to co-fund a trial you would have to know what the FDA will require for trial design, scope of the trials (HIV, difficult to treat groups, drug interactions, non-inferiority, etc).
But you would also possibly have to have an agreement on the payment/valuation of the percentage royalty that 450 will garner. This was STILL being worked out at the time of Enta's last stock pitch earlier in September, this month. I have to wonder if wonder if either side is playing hard ball with the other side on 450 valuation.
I also have to wonder if the same language or issues might pop up in the 493/530 (hypothesized) valuation discussions. IF there were a 450 sticking point, we might see a delay to start as a sign that they are both tenacious bargainers.
Both parties so far seem to be positive on the prospects for the 530/493 drug combo, going to phase 3 in 2015 and (probably late) 2017-ish approval.
It is also possible that Enta may be on the cusp of other either payment prospects (such as w/Novartis) or safety/efficacy reports on it's other unlicensed compounds that might be used as a decision driver.
There are a lot of ifs and moving parts, but I would sure like to see the trial start soon.
I wonder if they may be waiting on the price of Sovaldi/ledipasvir knowing there will be a comparator arm? Color from the FDA on scope of comparators?
I also could not figure out the point of a 12/24 week trial arm in the 493/530 2-a trial; more FDA guidance? I would not think a 24 week cohort to have much value in that 2-a trial. : /
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