Originally I was curious about why the FDA put it on clinical...

Originally I was curious about why the FDA put it on clinical hold, but apparently that looks like a check box exercise. One could argue that we have much more valuable data in humans but in reality if that was something the FDA wanted, well that's what they wanted. It's no different to what as previously been mentioned that we have ok tox studies but they don't meet the hourly testing or what ever is the standard they are looking for. To any of us, that appears silly, just use the data with slightly different test points, of waive that because we have safety data in humans, but once again the box needs to be ticked and there is obviously something specific they want.
one could argue that we are no closer etc and the FDA still don't know what they want, but I am sure conversations were had and continue to be had. At the time the hold was put on, that was what was required. Now though:
Now is a different scenario in my opinion. Once that data is submitted to alleviate the original request, it should be progressed rapidly as the FDA are publicly addressing change within including moving away from animal models and fast tracking drugs where there is urgent need.
It was probably a range of issues, including carnage when our application was reviewed within the FDA and data not exactly meeting requirements, but there seems to be progress within the FDA, clearer guidance and a genuine interest in progressing drugs that are really needed. Hopefully we are on our way soon! 5 business days remaining to see the pk data submitted and Parkinson's pre clinicals released!