Scuba, very nice DD and thank you for posting this unbelievable article!! This is a compelling drug as what my oncologist buddy said and supported by these paragraphs, the FDA insiders will see the light with this drugs approval:
The FDA’s committee finally acknowledged the complete responses in the CLL patients, but was still unmoved despite the unanimous appeal of the leukemia experts requesting approval. The FDA subsequently rejected Genasense® after suggesting that the small, financially struggling company just give the drug away under their expanded access program. Genta responded that they could not afford to give it away, and that the FDA non-approval was therefore a denial of patient access to Genasense®. Ironically, the FDA’s mantra is that the best avenue to patient access to new drugs is through approval, yet they refused to approve Genasense® despite compelling evidence of its efficacy and benefit to patients.30
Genta filed an appeal of the FDA’s decision in April 2007, but they were forced to reduce staff so they could stay in business long enough to appeal the FDA’s decision. Approval for use of Genasense® for treatment of melanoma was similarly denied. This was the result of an apparent mathematical error on the part of the FDA in analyzing the data. Genta is filing a complaint under the Federal Data Quality Act to correct the record, but meanwhile, melanoma patients have the same access to Genasense® as leukemia patients—NONE, except through clinical trials, which are continuing despite all adversity.30
This is the classic story of the small struggling company up against an unreasonable and often insensitive government bureaucracy. Caught in the middle are millions of patients and multi-millions of their loved ones. There is a saying that “he who saves one life saves the world.” Apparently, the FDA’s committee does not have this as part of its philosophy. This “process” needs to be drastically altered, and now, before more lives are prematurely ended.
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