Until the EMA meeting is over, and all parties (FDA, EMA, and IPIX) agree on the protocol, no one knows trial design.
It would be good to have different cisplatin dosages in various arms and that shouldn't be all that expensive to do that. However, the most common dosage in the future will continue to be the high dose, so that's the one that really matters. That's the dose most of the patients who need this drug will be taking.
And, as several people have pointed out, once something this convenient and easy is approved, doctors will be prescribing it off-label for people getting chemo/radiation for other cancers too. Most doctors would be much more hesitant to prescribe an IV procedure like Galera's off-label because of the expense and the risks of systemic exposure. Since Bril-OM has no systemic absorption, lots of doctors would look at it as being in the "can't hurt, might help" category and would prescribe off-label. In fact, I'd think doctors would be more worried about being sued for malpractice if a patient asked for Bril-OM and didn't get it, than they'd be worried about insurers and medical boards coming after them for prescribing it off label.
It would be good to have different cisplatin dosages in various arms and that shouldn't be all that expensive to do that. However, the most common dosage in the future will continue to be the high dose, so that's the one that really matters. That's the dose most of the patients who need this drug will be taking.
And, as several people have pointed out, once something this convenient and easy is approved, doctors will be prescribing it off-label for people getting chemo/radiation for other cancers too. Most doctors would be much more hesitant to prescribe an IV procedure like Galera's off-label because of the expense and the risks of systemic exposure. Since Bril-OM has no systemic absorption, lots of doctors would look at it as being in the "can't hurt, might help" category and would prescribe off-label. In fact, I'd think doctors would be more worried about being sued for malpractice if a patient asked for Bril-OM and didn't get it, than they'd be worried about insurers and medical boards coming after them for prescribing it off label.
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