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Astex Pharmaceuticals, AŞ Message Board

  • ripper99x ripper99x Nov 15, 2004 2:39 PM Flag

    why would they go to all the expense of

    attempting to get orathecin approval if they did not think they had a shot at it?


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    • I think that it is to save face. They've spent a lot of time and money developing this drug and have publicly touted in enormous fashion through the years. To abandon it now is out of character for SUPG, which has historically been a stoic company even in the face of poor odds. The fact is that whatever little revenue that would be generated from an approval is enough for SUPG to take the chance, where as a company like Abbott for instance wasn't willing to take the risk for such little reward. I believe that a larger company wouldn't have even gone to the trouble of filing an NDA for it based on the data they generated.

    • alot of money spent. They sold the right for production with another drug company just like dacogen. But it failed to be approved and with so much money funded would you give up. The stock back then was $80 a share. But this is a different situation where the key drug is not orthecin but dracogen. That's why I'm still hanging around however I don't know and have negative feelings toward orthecin. Today's news was something special.

      • 1 Reply to roryrae
      • Ripper, as mentioned by someone else here, the Orathecin protocol was written by the FDA. Here is something for those who researched this study to pitch in some addl info that I am lacking. The primary endpoints was not met, everybody knows that. BUT, remember that the protocol allows patient that failed other treatment to *crossover* to Orathecin throughout the study (again, written by FDA and not SUPG). Initially, the FDA only expected ~19% of the 'best care' patients to crossover to Orathecin which may not skew the survival benefits by much. But it ended up with 49% of the 'best care' patients crossed over to use Orathecin. Well, the primary endpoint as indicated in many report is dependent on the crossover effect. Remeber, there were 74% of the population received Orathecin, here is the catch, but the 49% of the best care patients that switched to Orathecin were not added to the Orathecin group, it remained on the 'best care' group. And because of the higher than expected crossover, the survival benefit was murkied thanks to the (IMO) inappropriate protocol by the FDA. However, secondary endpoints were independent of the crossover effect (this is a part that I haven't figured out why, but I take the words of the independent reviewers) and look at the effect for yourselves. Anyway, I'll stop here.