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Re: MrGuru post# 4969

Monday, 05/15/2017 7:58:38 PM

Monday, May 15, 2017 7:58:38 PM

Post# of 21521
I think one of the issues is the variability of results between patients. If they can measure the levels of each patient and then adjust, you can potential replicate results like the 76 year old (CU#3). Once they get all the data from the 2b trial and study it, it will make a huge difference planning phase 3.

Can you imagine if they can get even close to the results from the 76 year old (just using him since they have such specific data from such a long period of time)? They immediately raised his score, suffered a bit from down regulation around week 6-10, although scores were still 2 to 3 times higher than initially, before scores climb back to the peak and more or less stay there for an additional 5 months (6 times higher than initial testing) before tapering as the dosing study lowered amount. That would blow current SOC out of the water.

Similar results of the other 2 CU patients but for not as long a time due to non-related infections and help issues. Even out of the 6 patients with the single dose in the 2a, one improved 5 points in 3 hours, and 2 more 2 points. When we see the final 2b data here, I would be absolutely shocked if we did not see some higher individual responses and also based on the longer CU study, my guess is the scores were much higher than the +1.5 twelve week point earlier in the study and would have also been upswinging after week 12 and will peak closer to a score similar to the high point we may see early on at some point later than week 12. This is where the open label extension will be key IMO. If they can control the down regulation similar to CU patient #3, they could be maintaining a peak score 6-8 months into treatment, when SOC only stays above baseline for 12 or so weeks. JMHO
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