Ariad Pharmaceuticals Inc fka ARIA

[zuize]

TC, there is a good chance that 113 may get it's FDA approval soon....that could get us 30, Hedges Willing

Anyone know the criteria for a BTD drug to be approved via accelerated-approval? I don't see it would cost Ariad anything for getting 113 approved via this path, but it seems that they're not doing it. Thanks!

Below is a copy of the text from FDA website on Accelerated-Approval:

".... Accelerated Approval: This program can be used for speeding the development and approval of promising therapies that treat a serious or life-threatening condition and provide meaningful therapeutic benefit over available therapies. Accelerated approval allows approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
Thus, the accelerated approval pathway is most often useful in settings in which the disease course is long and an extended period of time is required to measure the intended clinical benefit of a drug, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Nevertheless, even after the drug enters the market, the sponsor may be required to conduct post-marketing trials to verify and describe the drug’s clinical benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.

Note that a drug that has received a breakthrough therapy designation or a fast track designation can be eligible for the accelerated approval pathway, if the relevant criteria are met.
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