The FDA is not only looking at efficacy more importantly safety....

The FDA is not only looking at efficacy more importantly safety. They will look very closely at trials submitted and look at dosing regimes and how Optimal Biological Dose (OBD) for a particular disease was clearly proven.

FDA doesn't like a one for all fit, It needs proof that the side effects don't out way benefits. They will want evidence of amount of drug taken and how long one has to take it for a measurable effect and are there any risks taking that amount over time.

If an applicant says benefits last for x days they will make the trial run for more than that time then look at any safety effects then efficacy, safety is always number 1, this is not a lifesaving drug so not as much urgency as many here think.
Lots of drugs fail P3 and are either stopped by FDA or applicant cause numbers don't stack up.

The FDA was concerned about the renal rat, that was a 1 off, they will want to know, what if the 1 off is 1 in a hundred or 1 in 10 or 1 in a million they will want that clarified and proof it doesn't replicate in humans, if it does how long is the effect? does it outweigh the benefits?

I think having data in multiple areas of treatment, OA, MPS, RRV, Chinka, doesn't help us, why? Is the same dose optimum in all areas or is a lower dose optimal in some etc. etc. I know they are targeting OA for P3 but to be having all sorts of data in other areas cloudies the water imo.
Remember P3 is not approval to market, a long P3 costs mega $, so this is a very long bumpy road ahead.

All IMO