Guys I'm with you here! I really can't imagine what is going on with the FDA. But I try to take in a balanced view. We have this spike of FR bashing here and over at the IHUB website someone posted a 100% on-time record for FDA HUD responses. So why haven't we heard anything? I hate to say it and it saddens me greatly, but what is going on with FR? He is not acting responsibly at this particular juncture.
i have to assume that at some point during the 45 days (which ended about 2 or 3 days ago) that the FDA requested additional info. So the question is: When did that happen? and does 45 days start agin from that point? Assuming no additional delays, we would be looking at March 15 at the latest for word from FDA. All imo based on the way i understand it. In any case, I sold another bio Wed and the money will be settled on Monday. I will add to my NVIV position as soon as it looks like it has found a bottom. I'm guessing it's pretty close to bottom here around $2. GLTA
It may be a lack of understanding of how the government works. Once the presidental ceremonies are over it makes awarding trials a lot easier for agencies like the FDA. Think of it as a form of validation.
I whole heartedly agree--I just wish the FDA would cut through all this burecratic "red tape" and allow these human trials to start already. I don't understand why the Christopher Reeve Foundation and other organizations that support and represent physically challenged individuals aren't going after the FDA to get off their burecratic "duffs"
The delay is not simply bureaucratic as you may think. There are many applicants and reviews being performed concurently in addition to other duties such as industry events, training etc. The FDA will do the right thing and it is likely to be this month or as soon as a a week or two.