I agree on all your points kid-they are good ones and I overlooked the accountability aspects. Whalen is the CEO or whatever and totally responsible for what is submitted to the FDA. But, he is not responsible, nor does he have any input to, the Administrations' approval process after that, unless asked by the FDA for more data or work to be performed, then he is totally accountable for that additional input.
I guess part of where I was going is highlighted right at the end of your message where you say he is responsible or accountable 'X1000'. Is that the same as if a child misbehaves, why give him or her just a time-out when breaking their arms and legs will teach them a better lesson? You seem angry or vindictive toward Whalen and I don't understand why? I read somewhere here that he worked in the pharma business before, but that doesn't mean he steered the ship through the FDA process. Wasn't he involved on the accounting side? That is hardly the regulatory side. If you told me that the company didn't have the money to hire top-notch FDA process nursemaids, or that Whalen simply shot his mouth off, I would believe that. Or, if Whalen did not know the FDA processes cold, I would believe that too. But it does no good to fester on the past-Whalen seems silent now-good. I want to focus on the facts that BIEL has applications with the FDA in play, received a non-compliance letter which it reacted to and BIEL has asked for OTC approval of products previously approved as post-op eye surgery Rx products.
