To: CENTrader who wrote (237 ) 3/10/1998 5:13:00 AM From: Shawn Donahue Read Replies (2) | Respond to of 1063
Bill, Your right Exten does have a "developed" Liver Dialysis machine with their proprietary SYBIOL technology...I should have been more specific on what I meant..in that it would be nice if they could get funding so that EXTEN would have the money to enter FDA trials ASAP, so that their product would be approved with whatever modifications that the FDA trials may dictate if any, so that it will be available as soon as possible to the estimated " 30,000 new cases that appear each year, and the 10,000 people that die annually." I realize that the FDA is the governing body for approving drugs and medical devices to ensure their safety for use by the American public...but if the Surgeon General is going to spend millions on a national public awareness campaign, with approximately 4 million Americans having incurable hepatitus C, and Surgeon General David Satcher has testified the serious- ness to Congress, that there is NO CURE AVAILABLE and that Doctors are SEARCHING for improved therapies and he was met with the following serious and receptive response from Congress: I don't see the harm, but definitely see the benefit of Exten contacting Surgeon General David Satcher and Republican Rep. Christopher Shays, who Chairs the house committee for human resources---FOR FUNDING and a STREAMLINED FDA APPROVAL PROCESS due to the seriousness and extremely urgent need for the product! ''These people need to be told,'' said Rep. Christopher Shays, R-Conn., chairman of the House Government and Oversight's human resources subcommittee. ''They need to be tested. Many will need treatment, and many will need to learn how to prevent further spread of the disease.'' He compared the government's inertia on hepatitis C to its early reaction to AIDS. ''Federal public health agencies have often pondered, but never implemented, a comprehensive response to this insidious infectious agent,'' he said. NOTE: the Senator compares the seriousness of Hepatitus C to AIDS and we have seen how much funding has been made available for AIDS...Also, this would not be the first time someone has approached the Government for funding...remember Lee Iacocca when he asked for and received government backed funding to keep Chrysler (and the 100,000+ jobs that would be affected) alive...To me Hepatitus C is much more serious, as you can't get more serious than life or death! Plus, this is not the first stock that I have invested in that needed to go through FDA trials and if you don't get the right political clout...its approval can be very slow. I used to own stock in a local laser heart machine company in Colorado Springs and the wait for FDA trials practically killed the companies finances!They had many proven prototypes but the FDA approval process was continually delayed by the FDA allegedly not having enough resources!In this case with EXTI having a viable product for Hepatitus C, when it is being compared to AIDs.. I'm sure the FDA could appropriate the resources with a high priority! Regards, Shawn