This is the nuts and bolts of it.
After raising $210 M from capital markets, PAR has only jabbed about 70 people with the optimal dose of 2mg/kg weekly in a clinical setting. To boot, the first trial, 005 was on a pain measurement scale not preferred by the FDA (KOOS over WOMAC).
The phase 1 of PAR002 failed. 008 trial results are not convincing anyone in the medial or investment field.
The FDA has some issue with the 2 mg/kg dose that PAR aren't completely forthcoming to the market. It is clear that there is an issue with safety profile over clinical benefit equation that PAR is jumping through hoops to continue on with. So the wild assumption that the drug "works" and is "safe" hypothesis is a) not confirmed by the FDA b) not proven by the clinical and road map choices by PAR to date.
And that's it.
Where we at?, page-335
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