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Sunday, December 16, 2018 12:23:26 AM
In response to your statement " don't think that "some additional lab or trial work needed to be done" meets that exception. It seems the statement even anticipates in their e.g. that a change to sachet packaging would be part of the initial meeting. If some kind of bridging trial was needed it sounds like they would make that clear at the original meeting. I get the sense that they would really rather not have a second meeting during that 30 day period, certainly not one that involves the full staff or any broad go/no-go type decisions."
Regarding the highlighted portion of your above quote, might it be possible they(ipix) request a 3 arm ph 3, rather than a bridging trial(sachets) followed by ph3, meaning they propose the ph3 for B-OM trial be comprised of 3 arms- the 2 arms of 2b(placebo and B swish and spit) as well as a third arm, the sachets?
That's how I would do it(but I'm an engineer in the construction field).
I feel the cartoon, linked below, is more humourous than refereneces of going over Niagra Falls in a barrel, though the latter(the fallas) is likely more accurate to date for ipix investors (at least the buyer got a swing in the end).
http://www.projectcartoon.com/cartoon/46980
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