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Dear Prohost

Do we consider Genta dead? Or there is still hope somewhere?   

L. M. and B.W.

Dear Sirs,

We all knew and said it  that the task of betting on Genta is not safe as the approval should be based not just on statistics, but on common sense. Our experience tells us that, when it comes to common sense, robots should be excluded. Genasense's target is unique and represents an important mediator for cancer resistance to chemotherapy and other treatments. In other words, it gives hope to those whose cancers have become resistant to the conventional treatments when added to them after their failures. This is what textbooks have confirmed. Genasense results have indeed validated textbook information. Adding the drug to the failing chemotherapeutic agents has indeed saved patients. The drug did not fail and the 7 committee's members' rejection was based on doubt about the extent of the benefit, not about toxicity or total failure. The drug worked and history has demonstrated that you cannot deprive patients of a unique drug that has a validated target because of doubt about extent of benefit. Many products were approved with this doubt in mind and nothing confirmed or erased this doubt except approving the product (if it is safe) and letting it be tried on large number of condemned people with various combination of drugs. This task can only be accomplished when used on a large population of patients in the market.

We are not alone with this reasoning. Three of the ten Committee members voted for approval. The FDA approved Erbitux despite the fact that the drug had not proven in clinical trials that it extended lives of patients and its benefits did not help a satisfactory number of patients during clinical trials. Being on the market enabled the drug to rewrite its story and history. It was tried in different combinations, it was given to varieties of patients to treat various cancers where the extent of its benefits were beyond the shadow of doubt. We know now how to use Erbitux  to extend lives and dissolve tumors, various tumors.

The same happened with many drugs where the shadow of doubt was not used against them but in their favor.

The difference between 7% and 17% efficacy seen as little could represent a group where thousands of helpless patients could be saved. Time alone will allow pinpointing the category that would benefit from Genasense. The drug that failed to please the seven members of the Committee could become the savior of the majority of patients that are carefully selected to receive the treatment.

We sincerely believe that the story of Genasense did not reach its end yet. The FDA, as history reveals has, in many cases, issued verdicts that were contrary to the committees' decisions. Also, do not forget the upcoming European Committee review of the drug. A different opinion there would change the history of the drug.

Best wishes

Prohost.

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