New interview with AVXL CEO has very good info.
Post# of 1460
Posted On: 11/10/2015 4:43:10 PM
New interview with AVXL CEO has very good info.
Much as I hate to send anyone over to Seeking Alpha, and especially since the interviewer was that Kanak Kanti De who wrote the soft bashing/damning with faint praise article about CTIX -- but, what Dr. MacFarlane says is well worth reading.
Interview with AVXL CEO:
http://seekingalpha.com/article/3672856-anave...6&dr=1
"I think people are losing sight of the fact that this was designed as a study to test safety, tolerability and bioavailability. Part A of the trial, if you examine the study flow chart, was extremely onerous for our participants, who had to attend daily for 12 days to receive study drug and pharmacokinetic sampling procedures that lasted several hours. They then had 12 days drug-free before the process was repeated. When designing the protocol the question was asked "what's in this for patients? They go through this onerous process, but have no chance to continue to receive the drug if they perceive benefit from it during Part A." Part B was thus added to the protocol partly to provide some incentive for volunteers to participate in the trial.
I think it's fair to say that we were not expecting such strong cognitive signals to emerge from a small n study that was not designed to capture statistical significance within the resultant cognitive dataset. To me it is very significant that all those who completed Part A elected to enrol in the 26-week extension, and as the first few patients began to return to the study sites for Part B visits we received the message from patients and carers that they wanted to continue on the study drug for longer, which prompted me to approach the sponsor to extend the study for a further 26 weeks."
Much as I hate to send anyone over to Seeking Alpha, and especially since the interviewer was that Kanak Kanti De who wrote the soft bashing/damning with faint praise article about CTIX -- but, what Dr. MacFarlane says is well worth reading.
Interview with AVXL CEO:
http://seekingalpha.com/article/3672856-anave...6&dr=1
"I think people are losing sight of the fact that this was designed as a study to test safety, tolerability and bioavailability. Part A of the trial, if you examine the study flow chart, was extremely onerous for our participants, who had to attend daily for 12 days to receive study drug and pharmacokinetic sampling procedures that lasted several hours. They then had 12 days drug-free before the process was repeated. When designing the protocol the question was asked "what's in this for patients? They go through this onerous process, but have no chance to continue to receive the drug if they perceive benefit from it during Part A." Part B was thus added to the protocol partly to provide some incentive for volunteers to participate in the trial.
I think it's fair to say that we were not expecting such strong cognitive signals to emerge from a small n study that was not designed to capture statistical significance within the resultant cognitive dataset. To me it is very significant that all those who completed Part A elected to enrol in the 26-week extension, and as the first few patients began to return to the study sites for Part B visits we received the message from patients and carers that they wanted to continue on the study drug for longer, which prompted me to approach the sponsor to extend the study for a further 26 weeks."
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