RE:RE:RE:Well I guess we can forget about...Macer, you're out of your mind.
The IND was submitted at beginning of Oct. By rule, FDA must respond with questions within 30 days, or it's automatically approved. This means that the FDA had already asked for more clarification by the end of Oct. The company didn't bother to inform us of this fact. So the company responded to the FDA's questions, and this response was so concerning that on Nov 25 the FDA issued a Full Clinical Stop! Wow!
Think about that. And then tell me again this isn't a disaster. Esp when you realize that this roughly six month delay (and that's assuming we get this all cleared up and approved by April) will cost the company over a million dollars at the current burn rate (as revealed in today's PR). But there's nothing to see here and all is well? Are you nuts?
Again, I want to know who was responsible for this debacle, and what consequences they will face. I will call the company next week to let them know exactly what I think, and to demand some accountability.