Lets get this straight. Are you saying that 2mg/kg
twice weekly was not included in the stage1
dosing trial, because they were not confident
of a statistically significant result for that particular
dose and/or all doses?
This was a 478 patient stage 1 trial and if 2mg/kg
twice weekly had been included, then 478
divided by 5 gives approx. 95 patients for each
treatment arms plus placebo.
If PAR was not confident of a favourable outcome
from that size sample, then oh boy we are in
potentially big trouble with the rest of 002 and
003. What, where, when previous result would
have shaken their confidence thus.
And potential partners and FDA are not complete
fools. If what you a suggesting is true, than there
is a whiff of MSB trickiness about this.
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