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Posted On: 01/06/2022 5:24:14 PM
Post# of 153965
Re: generactor #114046
I get that, but my point is the BTD designation is only given to one drug.
Let’s say you have two drugs undergoing trials. The first to apply for BTD extends life by 12 months and the second 13 months. But the first drug applied a week earlier and by the time the FDA looks at the second… “Oops sorry we already gave the BTD to someone else.”
It’s not an Oscar so give it to two drugs to enable them to move forward faster and raise funds easier.
The “Highlander Rule” (There can be only one) just seems so arbitrary.
Let’s say you have two drugs undergoing trials. The first to apply for BTD extends life by 12 months and the second 13 months. But the first drug applied a week earlier and by the time the FDA looks at the second… “Oops sorry we already gave the BTD to someone else.”
It’s not an Oscar so give it to two drugs to enable them to move forward faster and raise funds easier.
The “Highlander Rule” (There can be only one) just seems so arbitrary.
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