Very difficult to answer this one Bobsee...
I tried to guess the same answer for our IND...I got it wrong by a factor of about 7 ..nod to Anchor_dude.
SO...slightly pie in the sky, Id like to think its (FDA feedback) a couple of months away...hopefully sooner but one must also build in some fat. I know we have had to do this sometimes in the past eh'?
However, this will be a pivot point as if its good and importantly, clear, we can then be certain of what is required to get this over the line.
Don't forget, once we start, the countdown begins...and according to me it shouldn't be an onerous one...we aren't talking 3500 patients over 3 years...we aren't talking multilayers...with huge crossovers and a complexity to rival the Particle accelerator system (Sorry, it was a bit topical) in Geneva.
We are in a very unique position here...we have already had a couple of really good P2's....005 and 008 blew the lid off. We now need that data in more numbers but not stupidly huge numbers...because of those two magic words that help me sleep at night....
Statistical Significance.
P3 go ahead should really follow shortly after...but its always better to be prudent again, and build in some fat...
If I were a guessing man...(betting man?) Id say sometime in Q3....Q4 isn't out of the question of course. Then we have a year....one year....that's all...sounds like a lot?
Mate we are already nearly in March of this year, where has it gone?....I've been waiting for this baby since 2015 effectively. I can wait a year.
I also presume we would start materially going up before that read out....
Personal thoughts
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