so..the WHOLE POINT of this study was to show SAFETY, PK, Max.Tolerated Dosage, 5Omg and maybe get a sneak peak at EFFICACY.
The good Dr. accomplished ALL of the ABOVE!
WE accomplished ALL OF THE ABOVE! A+ Right? I mean our Max Dosage could have been too little..
We could have had Aricept's Saftery Profile..(you ever seen that?)
AND we KNOW we have PK..We have ACTION!
ALL this so that if Patients WERE getting better, than Phase 3 would be successful. Do you know that the Fail Rate in Phase 3 is OFF the Chart.
Talk to Biogen if you want to hear about Failure in Phase 3..OUCH.
I think and I am with you..that what they found, is exactly as you say.
Follow the Yellow Brick Road. Monotherapy with A2-73 so that it may someday be the new Aricept and when drugs using different mechanisms come along, THEY may do studies with A2-73.
Look, I honestly think Anavex thought this data was positive.
When I crunched the numbers for ADCS-ADL anything around 70 at 26 weeks was a home run! Looks like the average with ALL N=27 is around 63..those with Aricept 62?
so at 5 weeks we had 64 average for group at 26 weeks we had 63..it is stable..
Taking the ADCS-ADL Scale from 64 at 5 Weeks ..the USUAL Alzheimer Patient 5 Months later would probably have scored below 60, as regression for Alzheimer Patients with Mild to moderate Alzheimers is liners with ADCS-ADl a litle less than a point a month. 10-12 Points over a year down.
and EVERYONE on the Yellow Brick Road Group did OBVIOUSLY BETTER..
I don't think the beginning score of 70 was accurate and I have posted why. (How do you drop 6 Points in 5 weeks? Not really possible in Mild to Moderate Ad- I don't believe the starting number 70 was accurate)
The Phase 3 in my opinion should focus on Monotherapy and have an arm of patients that do not want to give up Aricept.
If I am a patient and looking at these numbers..it is hard to consider not going Mono. They should GIVE THE Continuing PART B Patients that CHOICE and then MONITOR the results.(this will not be the last time I make this suggestion)
I was looking for a continuation of the positive trending of Interim 12 weeks...it didn't happen..i think the good Dr recognized this Data at 26 weeks and did not want to pump up the stock by releasing full 12 week data..remember this is an OPEN TRIAL ..they have DATA for many patients for over 52 WEEKS. It is Obvious that the good Dr. can not win..so I understand WHY we did not see any Interim Data at this phase.
So time to get over disappointment. Re Check the Positives and Negatives.
Are people getting better? YES ..we know at least 10% got a LOT BETTER!
Looks like those ONLY taking A2-73 are STAYING BETTER LONGER.
The Mono-Therapy pool is about 20% of Phase 2a..They should be more than 50% of Phase 3..
Let's go already with Phase 3..
The good Dr.needs to earn his pay raise that WE GAVE HIM..
Come on!
