RE: New FDA Alz. Drug Review Process......Bellini
den....."All Bellini had after fudging around with the statistical numbers after 'Alzhemed' Phasell (RECALL HE OMMITTED THE DROP-OTS FROM THE FINAL DATA!!) "
.....Just wanted to clarify that the Drop-Outs decided to not continue due to NO-EFFICACY.....how can you just omit them from the Data.....Bad Move!!! Lots of jousting with the FDA after that. The Alzhemed Trials will be seen as the Text-Book Example of "How NOT to Run Clinical Trials 101".
There were no preclinical studys that showed that 'Alzhemed' could have a chance to be administered to ANY mammal let alone a Human in the Dose Required to get the drug to the brain in quantities that would combat Amyloid beta 42....... OR Ab-40 for that matter!
'Alzhemed' just plain and simple DIDN'T GET TO THE BRAIN.......its not even a debate anymore! Get over it Bellini.
AZD-103 HAS the Goods. Successful Phasel's in HUMANS (healthy volunteers) show that AZD-103 is absorbed by the gut at a rate of 85-90% and Gets to the Brain in quantities easily, shown to STOP the Disease . Gets to the brain in quantities shown to REVERSE the disease. AZD-103 Gets to the Brain in Humans AND is SAFE in Humans. Tolerable in Humans. Crosses the Blood-Brain Barrier in Humans. Has a plasma value of 65% in Humans. Is safely and easily excreted by Humans. AZD-103 has been administered to over 110 Humans so far with a few hundred more Human Patients slated to Start Human Dosing coming up Pronto. Hey...maybe thats a good name for AZD-103.....'PRONTO'
So far AZD-103 has paralleled the pre-clinicals positively in EVERY aspect. A good case has been made for AZD-103 to be an Effective Beta-Buster in Humans. Pre-Clinicals not just showing the Mechanism of Action (MOA) of literally dissolving Amyloid beta plaques ('Alzhemed' reduced the stickiness but didn't flush them)......but COGNITIVE proof of effectiveness resulting from that MOA, in animals, in two seperate very different studys as stated in 'The Patent' application.
Good case has been made for this Drug to be effective in Humans. Note that NO-ONE has made a case for this drug NOT to be Effective in Humans. NO-ONE.
Have a look at the lever-pressing task... https://www.stockhouse.ca/bullboards/viewmessage.asp?no=16724984&t=0&all=0&TableID=0 .....That was a BIG Gamble by Transition to let Dr. Selkoe run that Study!! At this stage of development with the Human testing confirming EVERY pre-clinical MOA related test, this is now PAST the "Cautiously Optomistic Stage" and moves into a higher rank for ME.