Blane, about dosing. At some point MGMT has to realize they cannot provide guidance of a couple of weeks back in the end of January to now being 3 full months and counting. I have no problem if they are getting decent numbers of volunteers but aren't yet comfortable with one meeting the stringent requirements fully. Yet I am beginning to fear that they have not screened many at all, because they didn't fully plan and anticipate the protocol difficulties they would face. Perhaps dosing on healthy patients for cohort 1-2 for the safety studies they need and then moving on from there.
What motivation would a relapser have for being in cohort 1, getting a sub therapeutic dose and then never be allowed to get dosed again. (Unless they are offered Gilead's treatment as a reward for being sub-dosed safety guinea pigs, or some other incentive.
Bottom line, I am way long and strong on Benitec and TT-034, but if they don't get a proper patient dosed soon the whole study could be dealt a serious blow and may involve having to change the protocol for the study.
Management needs to give us another update....how many have been screend and rejected? How close are they to finding a suitable first patient? What is the back up plan if they don't get one by June 1st (to throw a date out there that I NEVER thought we would be considering.)
I think we deserve answers because I truly think that it will become an issue pretty soon if they don't succeed with getting that first dose administered, there is nothing left to do but a costly time consuming change to the study protocol.