I want to take a stab at this, but you gotta understand this is completely my own interpretation, I could very well be
TOTALLY COMPLETELY FANTASTICALLY COMPREHENSIVELY
Wrong...
The FDA are on our side. It may not look like that, it may not smell like that.
I will grant you that they seem to be a cautious and safety conscious bunch.
Ok so we had 6 Q's...we made it to 1. We then were pointed in the direction of Clinical Monitoring...for something that doesn't have a big chance of appearing in a bigger animal model let alone humans. From the FDA point of view, that's maybe not the point. If they think there is any chance they are going to rule it out.
So why didn't they do this in the first round and save us the hasttle, the effort? Well because it takes time to go through 30,000 pages when you have a Covid-load of other approvals going on at the same time and you are prob. short staffed. I'm not making excuses for them, I'm just imagining what it might be like. Yes I agree with Ceviche, it's not great for us investors to be idle...but this is necessary game plan and we need to do what the Ref asks. Remember, if you are new to us, if you are new to Bio Pharm plays...and heck, if you are new to companies that are pre revenue stage...you got some waiting to do...this isnt a stock thats going to get massive overnight fans of Reddit or Millenials jumping on board and forcing us up (maybe that happens later?)...we have to pass the big hurdle first...and then get some good data to back us up at a P3 Level.
I'm also not saying we have been totally idle, a number of things have been progressing in the background during this time, not all are evident to us.
Speaking of what the ref is saying...this might be the reason why also they didn't just tell us what to do....THEY CANT!
Remember that interview with the Industry expert we did? I remember him saying that the FDA generally do not tell Sponsors what to do. Why? Well one reason could be it's potentially risky...if the FDA get real specific and say, do this test for exactly 400 patients and if something goes wrong, they could have litigation on their hands. I'm not saying they don't give sponsors pointers, guidance and the like, but it is more questions or proposals coming from the Sponsor. This slows the process down....now add the fact that as Dr Skerrett very plainly said, in the old days it would be a 20 min on the spot phone call to clear any questions or garner more detail, nowadays we are in this 30 day written cycle.
I liken this process to going down a funnel...we are getting closer to the spout...yes it seems they are going around and around in circles answering the same question over months, but I don't think it is quite as bad as that.
Getting closer to the final spout!
7 days plus 30....we are getting there.
My views here
ps: Yes AF - I'm setting you up for some weird Theme PARk meme...
(20min delay)