This is not my first rodeo with radiogel submission to FDA. I had and held through my shares through the de nova and first IDE submission. In both cases investors felt approval was a slam dunk. Were you invested and go through both of those events? I think we have everything we can possible cover covered this go around. But how many times have we been jerked around in the past, so it is on my mind the FDA could do it again. Specific examples are the genotoxity testing (that no other brachytherapy product ever had to do) and extra rabbit tests. You have to admit the extra rabbits were a total moving of the bar that the FDA itself set.
I feel the problem with the FDA is it is full of civil servants with low pay making critical decisions and some of these FDA people have relationships with big companies that involve them getting a high paying job a few years down the road. The concern that government regulators make decisions that are influenced by future job prospects in related industries is legitimate and puts small companies at a disadvantage. Look at the fraud Boeing was recently charged with all the questions Boeings ability to police themselves (a gift handed to them by the FAA) raised in terms of why the FAA didn't do proper oversight of Boeing.
There is nothing investors or any small company can do about that. But it is on my mind.
Just think if you hadn't annoyed me with your post I would have not shared this more descriptive post of why I am anxious. I don't think the FDA can hold up radiogel from being approved forever. At some point they have to realize they have squeezed as much extra time before the approval as possible.
Now I expect to see a bunch of chicken little responses claiming I think my posts are going to make people sell. Maybe I won't maybe everyone who doesn't want to hear from me have me on ignore. No one should sell because of this IDE not being approved without any conditions or a little later. We are closer and the payoff will be huge.
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