The view within PAR is that the answer is "in the data" (That FDA already have in their possession).
What could possibly go wrong with that view?
....
The fact that the data is a set of numbers around which statisticians imagine a representative distribution.
eg Normal, Poisson, Cauchy, Student-t, Gamma, and the blessed one 'empirical'.
What could possible go wrong with these (apart from picking the one that is not in the mind of the FDA).
One answer might be to run further clinical trials at three different dosage levels and point out the margin to the dosage levels for humans. That is my guess as to what isn't there, notably discrimination on safety and side-effects, with a study of sufficient size to reach a sound conclusion
What we know already is that PAR management and board failed to anticipate nit-picking by FDA. It is clear to me that FDA have an agenda to delay to do just that. So, trying to tell FDA they already have the answer to their question is not smart. Perhaps some posters should be asking PAR management are they sure they have covered what FDA might want/need to hear. (eg: 3 trials with dosage levels to show safety).
I remain unconvinced that PAR management understand RISK management.
In the absence of that there is risk of a further delay.
Which explains the charts, sort of. You know, the obvious down trend and the pious hope for an uptrend (even before news!?)..
and GLTAH.
PS. On Aug 3, Bell Potter came out with a slightly lower price target viz, $3.00.
All just IMO. DYOR.
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