This debacle shouldn't be a surprise if the Aveo management had disclosed the outcome of pre-NDA meeting held in May 2012. The FDA had clearly told Aveo that a second study is required and also mentioned other concerns!!! Besides, there was no submission of phase III protocol to the FDA for their review and comments prior to the start of the trial, I am not saying that one needs an absolute agreement on the design of Phase III design from the FDA but at least Aveo, if they had submitted the protocol for FDA comments, would have known what the major comments were Vs minor comments and they could have assessed the implications. But they didn't!!!! It appears that the management arrogantly went ahead without consultation on the trial design. On top of that again they went ahead arrogantly to submit the NDA paying 1million dollars knowing FULLY well that they were told last year that they needed a second study!!!!
Just as an fyi, at a pre-NDA meeting it is customary that Aveo submits phase III results on a confidental basis. So my point is, Aveo knows a year ago what the outcome is going to be!!!
Folks, please be careful with this management. I am not really sure what their clinical and regulatory head advised after the pre-NDA meeting??? are they that incompetenet??
Yeah, until those docs were issued we had no clue.
They will LOSE this lawsuit. I get so peed off that these small bios omit so MUCH valuable information that just HURT their shareholders. It is sickening and has cost me a lot of money.
WHY would they omit this info?? The CEO has to go, there has to be a lot weed picking and it starts at the top of the Board to the CEO.
You can't take SHORTCUTS and expect it to bode well with FDA. Between CLSN and AVEO, I am down this year at of all the years that should be easy money.
It all has to do with CEO's not being truthful and witholding information that would defiinitely indicate a SELL signal.
These class action suits don't pay much and fill the lawyers pockets full of cash and the shareholders get a double sckrewwing!
So I will just have to bend over and take a very large one up the crack hole.
August, 2012 CC:
Salveen J. Richter - Canaccord Genuity, Research Division
I just wanted to follow up on what Tom was saying. So when you met with the FDA, and they brought up their concerns, did they kind of point you towards a direction of what studies they wanted to acquire? And when you commented on these analyses that you're doing, were they comfortable with that? Or did they kind of push you into a different direction of maybe doing some additional new analyses or additional studies?
William J. Slichenmyer - Chief Medical Officer
Yes. So we're not going to get into the details of our ongoing discussions with the agency at this point. And really, the key thing about our updating today is because of the potential impact on our NDA submission timeline. And so regarding any future study, I think again, I just can't speculate on what the agency might want us to do in the future.
Really should have read between the lines there. D'oh.
I will say that I believe not disclosing the FDA suggestion of another phase III last year was a substantially material omission (assuming I didn't miss it somewhere in the record). No expert on security laws but, my god, how can that not be a material matter requiring disclosure? ah well... live and learn
100% agree. Suing is not just for money but also for valuable insider information on some of the discussions taken place via emails amongst management and employees after the pre-NDA meeting! We wouldn't have know if not for the law suit against Merck, Pfizer on how the senior executives knowingly pushed for unsafe drugs to be marketed e.g. Cox-2 drugs.....
I am surprised some posts are playing blame game on FDA etc.....What Aveo did is unacceptable! PERIOD!