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There are a lot of questions that need answers. My confidence in SUPG is rapidly diminishing, particularly after today�s events. Here is why:
The FDA �approvable letter� for the Dacogen injection was received on September 1, 2005. The letter provided that the Dacogen injection is approvable pending the FDA's review of a requested analysis of the transfusion requirements of patients enrolled in the completed phase 3 trial, submission of certain other information, and completion of labeling discussions.
My first question is why did SUPG not anticipate any of these items, thus avoiding delay in approval? Second, why did it take ten weeks to respond? Third, based on the September 1, 2005 receipt of an approvable letter - instead of an approval - did SUPG take any immediate steps to determine the impact the situation with the FDA would have with European regulators? Fourth, precisely when did the European regulators indicate to SUPG that they would require additional clinical data on the use of Dacogen injections? Fifth, when and what steps did SUPG take to determine the nature of the additional information sought by the European regulators? Sixth, am I the only one that finds it suspicious that these two announcements came out on the same day (e.g. SUPG announced its submission of their response to the FDA�s approvable letter and revised European strategy? Seventh, the announcement with respect to the European regulators indicated, �the companies said they plan to resubmit the application at a later date, possibly with another partner.� Who is the �another partner� and what are the details?
we are here. we can't go back. you make no money beefing about the passed. if the data supports the application we will get approved. that is what counts. that is what the fda wanted and supg delivered it. we the application is scheduled either as a class 1 app, or a class 2 app we will then know the timimg of the review.
There is only one question that need be asked. Dose the (new) data submitted provide the right information to get the drug approved? SUPG says it dose. If that's the case the drug should be approved by next first half of next year.. All those other questions don't mean a thing.
Why would anyone in their right mind, a person who is worth billions of dollars named Kirkorian buy a company that might go bankrupt. Why would you a buy a stock that has no real revenue, has no pipeleine like supg against something which give a dividend of 9% which is considered mom's apple pie GM. Gm is down 40 percent while supg is breaking even from the beginning of the year.
Answer my question and then I'll answer yours. Go figure. If your confidence is gone then sell. You probably will break out even if you get out now.
Your question was actually three.
I can't speak for Kirkorian, but with his money, there are a variety of reasons to pick up companies near bankruptcy. If there are assets of value, or any turnaround potential, there can be a great deal of money to be made. As for my investment in SUPG, it was based primarily on what I percieved to be a better than average probability for Dacogen approval. As to GM, anybody that can do any research knows it is a finance company that loses money on cars due to union burdens. When you lose up to $1,000 per vehicle, you can't make that up on volume.
Now, as promised, please answer my questions. Thanks.
There is only one question that need be asked. Dose the (new) data submitted provide the right information to get the drug approved? SUPG says it dose. If that's the case the drug should be approved by first half of next year.. All those other questions don't mean a thing.