You're right about that. Not many brave enough to target severe. I think Alkon did the right thing by going after that sector. No questions as whether individuals had been misdiagnosed or issues like that. I do however think they may have made a mistake with the original trial design as far as alternating the 20 and 40 doses over 12 week intervals. I understand the hope of the larger dose providing even better results but 20 to 25 ug had been used with significant improvements on the compassionate use patients and at a minimum, they already new side effects would be worse with the higher dose.
I mean the company now knows what dosage to use going forward which is a big plus, but they still need to come up with optimal intervals to give the drug. If they had to revise the trial midstream due to 40 ug side effects, which apparently they did, it would have been really beneficial to bump the 20 ug patients from 12 to 24 weeks while they already had them on the drug. Looking at the CU patient results, the averages of the 35 or so patients on the 20 ug in the 2b study seem to match up well and if that pattern held (which is certainly suggested from the data presented in July regarding the 17 week data point and comments made by Wilke earlier) then a 24 week study could have been blockbuster for us. Instead its caused a major delay.
Can't wait to see further results as the 10q stated. Would really like to see if any larger response in APOE4 patients. Wonder if this could be a reason for Dr. Perry signing on?
