Post by
HighteawithIntrepid on Feb 13, 2016 11:12am
Time lines
Until we have our conference call and the range
of what several months means we are just guessing.
My dictionary says several means more than 2.
So the optimist says 3 months and the pessimist says 9 and
the mathematician says the average is 6 and the actuarial
mathmetician says well there are a lot more optimists than
pessimists so let's double count the 3 and then divide by
3. So 15 divided by 3 is 5.
The most important thing is to get confirmation from the FDA
that they consider MCNA safe.
Secondly if we use the same parameters as our 129 person
study how many warm bodies do you require us to enlist and
thirdly can some of them be in Japan.
HT
Comment by
Frogger2 on Feb 13, 2016 1:07pm
Totally agree empty. Since the ADCOM sideswipe and the FDA head on collision they have no clue what the trial will look like. Until the FDA meetings happen it makes no sense to consider a trial and may not after that. They were apparently working closely with FDA through this whole process and look what happened. I think our path now is another country approval.
Comment by
HighteawithIntrepid on Feb 13, 2016 2:44pm
Think of it as a game of tennis or ping pong. We make the first move then the FDA responds and we respond to the FDA and then they consider our response. but each serve and return takes 30 days not 3 seconds. So find something to do to make the wait more tolerable. HT