RE:FDA Additional Information (AI) RequestAlthough this is only my second post to this board, I have been following it daily for at least two years.
In addition to the life-changing potential benefits of this medical device, the comprehensive financial analyses and asute insights provided by Prokofiev are the key reasons I decided to invest a substantial allocation of my overall portfolio in Helius Medical.
Relative to all of the stock bullboards that I have followed over several years, I have never encountered a more knowledgable or accurately predictive poster of information than Prokofiev.
As such, I appreciate your summation of the recent turn of events with the FDA asking for more information, and I am trusting that you are (as always) probably correct in that things haven't changed much from a fundamental perspective.
My outstanding questions are, however, what else could the FDA possibly need to know, since they have been working so closely with the Helius team on the approval process?
Why is Phil Deschamps saying, "We believe we have the data and information to address the FDA's questions." Shouldn't he be saying, "We are confident that we have the required data and information..."
Why was approval given so quickly by Health Canada and the US FDA needs more convincing evidence?
Do you think the odds of final approval have gone up or down with this current delay?
If this is just another bump in the road, shouldn't we all be taking advantage of this brief drop in share price and backing up the truck?
Feel free to ignore this, or reply to any or all of it.
I'm still in for the long haul, but a little more nervous after this tumultuous week. Hopefully it's just another of several bumps in the road.
Thanks,
Hoptimist