First CRL Issued March 2010, Resubmission September 2012
It took a year and a half and they still couldn't get it it right.
It puts into question the competency of management.
Does anyone have confidence that they will get it right on the third submission?
Another year and a half wait for who knows what.
The Company was founded in 1983.
Nothing approved in 30 years.
What does that tell you?
I am in for 40k loss (haven't sold yet). I am disappointed, so far this is one for the WORST management i have seen. I am 100% sure next time it will be CRL. look at them, the first 2 FDA concerns are same "HOW CAN YOU DO THAT"
You took 2 years for what? does FDA talks Roman?
Something happened. This company has a good deal more money than most. You guys don't know the definition of wait. The company first need to meet with the FDA and see exactly what they want. Additional clinical trials aren't necessary and the CEO said drug launch in early 2014 not early 2015. That is 9 mos. How did you get to 18?