I'd like to express a view on the progress of the phase IIb trial.
On Dec 15 2011 twinpeaks posted the following, paraphrasing a comment from Martin Rogers, at an Ord Minnet presentation in Sydney: (#7548695)
"Getting down to the nitty gritty PRR is expecting initial results from the llb trials around June 2012 or perhaps 6-9 months after. At this stage all the patients are in good health so we may have longer to wait."
Now I wasn't at the presentaton myself, but I have no reason to doubt that this was an accurate quote. And none of the subsequent posters in the thread suggested otherwise. Eg Brainybull said of twinpeaks post at the time:
"You have articulated well the proceedings of the meeting with MR." (#7548945)
So if 'all the patients' in the IIb trial were healthy at that stage,(ie 45 receiving cvac and 15 in the standard of care control group) I just can't see that things would have changed so fast, to cause appreciable differences in the health profile of the two groups, so that just 7 weeks later, the FDA would deem the IIb trial a success and authorize a phase III start.
For me the FDA must have had other considerations, eg:
*orphan drug acceleration,
*shortage of current standard of care drugs (fazz03, #7765875),
*earlier I/IIa results and the safety profile so positive that there was no perceived down side in running IIb/III concurrently,
*and, PRR organised, cashed up, and keen to proceed.
Like a lot of you, I've got a fair bit staked on PRR, and I've been that way for 3 years now. I'm very happy with current SP strength, but I just don't want to get carried away with presumptions that the IIb trial is a success, when I doubt that there is a sound basis for the conclusion.
Would be delighted to be proven wrong though!
Good luck all. Herro
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