I agree @FloatingCity, it's worth keeping in mind that an ODD awarded to a company for a particular drug for a particular application, only becomes useful if that drug is approved for that use. If it's not approved for sale, the ODD ceases to be of any use. So really the committee only has to consider if ALS treatments meet the criteria and if the drug has a reasonable chance of being approved.
Well that's my understanding so I would appreciate being corrected if I have misunderstood.
Now where it really gets interesting, is the same committee appears to also be tasked with managing a large fund set aside to assist finding a treatment for ALS. [Refer to a great post by @Quiltman a few weeks back.]
If they think a drug is worthy of ODD, should they not also consider it worth of funding ? Could this have played a part in requesting further information on MPL in animals ?
I'm really not sure how much of a boost getting ODD granted may provide, as the market is pretty unpredictable, will FOMO set in, or has the market already built it in ? Who knows.
But it will be a very big deal for any BP's that are watching. An extra 7 years exclusive marketing [Out to 2037 I believe] how much does that increase the base value of PAA. ???
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