I can't help but think the time the FDA has taken indicates that more work needs to be done than originally anticipated by PAR management. It may be straightforward, about numbers to support the statistics. It could still be about dosage, or about more stats to support that.
If the FDA response comes soon, we are back with a slim chance of a favourable SP response, depending on how much extra work is involved over the hoped for just 300 patients in trials.
IMO a deal is necessary before the options expire. I would much prefer that over another CR.
DYOR.
PAR. SP, page-1123
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