RE:Down to the Short Strokes!!On what planet is this considered going in the right direction? SMH. It would help if they would clarify what is bugging the FDA so much that they are not willing to accept all the compiled and certified data so far. Twice. Something's not adding up. They'll need more money soon. Sigh.
Infinity wrote: The NR today certainly appears to be going in the right direction as we all anticipated. Pre-BTD application is just a formality. Hope they get it right the next time. The way that I look at it is, Pre-BTD is more of a filtration process. It is not an Yes or NO process. It could take a bit longer. The current Data easily supports a BTD approval very very soon.