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Thursday, July 16, 2015 10:42:41 AM
WolfWayne:
Phase 2b could be combined with Phase 3 under the FDA's Accelerated Approval Program if 2a results are that good? The adaptive trial design can accomodate this?
I have a hard enough time figuring-out filings. Speculation can lead to frustration. Best to ride the train and relax instead of running alongside waiting to hop on.
The wiki has some good info and points to things to consider here as far as the 22nd being some major catalyst.
According to FDA guidelines, an adaptive Bayesian clinical trial can involve:
*Interim looks to stop or to adjust patient accrual
*Interim looks to assess stopping the trial early either for success, futility or harm
*Reversing the hypothesis of non-inferiority to superiority or vice versa
*Dropping arms or doses or adjusting doses
*Modification of the randomization rate to increase the probability that a patient is allocated to the most appropriate arm
The FDA info:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDIQFjABahUKEwi31Y779N7GAhUGEJIKHQ51A_Y&url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FDrugs%2FGuidances%2Fucm201790.pdf&ei=dkCnVbfCLIagyASO6o2wDw&usg=AFQjCNHVnJB5GAQCyzkur1aYs6nwORYk8A&sig2=Wol3qdBshLK0xjd-Y8400A&bvm=bv.97949915,d.aWw&cad=rja
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