Why this was not a conditional approval is beyond me
Titan already proved this was safe and effective and Adcom agreed. This should have been a conditional approval in the worst case scenario. They could have done a follow on dosage study to determine optimal dosage if the FDA needed it. This is a complete cluster-f*** by the FDA.
There should be a LAW stating that the FDA should not Accept an NDA if this was on their little worry minds.
They play with the pharmaceutical industry and reap the benefits by having their friends and relatives get rich by legally stealing money from shareholders who have placed their heart and soul into this
As I stated; before they announced, I would not be surprised if they issued a CRL.
Nothing but a bunch of Dsy- Regulators
I think this was just a CRL because they got to thinking that everyone would want one of these implants...then thought, well...this may not be good for the long term...then, what if this isn't safe....then OMG, what about the dosages...was this explained well enough.
The FDA are the ones at fault as they should NEVER accept an NDA if this questions in mind were not settled.
Why have an ADCOM? Why?
Pure Corruption and Suit Cases filled with CASH!