How would he know this if the facts are not coming until the meeting? Besides, I thought the "letter" said safty and effectiveness deficiencies. I think this is the same wishful thinking that got us in this mess to start with. At this point I am only interested in what the FDA has to say. Why? Because as I said on Black Friday 9/25, this company is on the block and the price it goes for will be greatly dependant on what the FDA has to say... not what the company "spins." BT has either mislead investors with his "spin" or he is in way over his head. We need a seasoned RE Agent to manage the company now through its sale.
You do not have to wait until the meeting, the details were stated in the letter, which by law, the company cannot disclose. As far as the letter saying safety and efficacy failed, this is not true. Stop playing with the words. The letter said they were not approving based on deficiencies in the safety and efficacy DATA. The only DATA that was sent was safety and efficacy. Therefore, if it were only a regulatory issue, it would still be a REGULATORY ISSUE REGARDING THE SAFETY AND EFFICACY DATA. Everyone keeps reading this wrong and assumes it means a problem with the science. Also, the letter said there were deficiencies, this word means (not enough). It does not mean, errors, or mistakes. This coincides with the info that I have that says the new FDA lady feels that there is not enough data...however, we all know that there is, and if she's not happy, theres more in the SAP trial. If I had more money, I'd buy more, but instead I bought some calls. Stop analyzing the wording of the letter and focus on what is important. They need to correct a problem and then they will be approved.