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RACE Oncology Valuation - June 2020, page-130

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GeorgePower

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28/07/20

11:54

Post #: 46121036
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Originally posted by RaceOncology: ↑

We can’t advise when we supply bisantrene under compassionate use or the outcome of that use. I can advise that our compassionate use program is ACTIVE.

You do raise a very good point that I think many people might have missed and that is the Sheba results suggest a viable pathway to approval for bisantrene as a single agent treatment for R/R AML. While combination treatments are likely to work better than bisantrene as a single agent, it would be much faster to go for single agent approval as it would stay on the 505(b)(2) pathway. We should not let the perfect be the enemy of the good.

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Can the results from Bisantrene when supplied under compassionate grounds be used in applications to the FDA?

RAC Price at posting: 89.0¢ Sentiment: Buy Disclosure: Held
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