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Monday, April 15, 2019 8:12:12 PM
SAP this year. Hands down. There would be no excuse for it not to be submitted this year. None that I would except without making a big stink about it, along with Flipper, I am sure.
As to when it will be finalized, or approved, or whatever the heck it's called, I would hope soon after it's submitted, if it hasn't already been submitted. 30 or 60 days afterwards? But will there be FDA comments that require changes to it, or will it be smooth sailing? I think that's what could hold it up, or end the multi-month process in a reasonable time.
I'd like to think September at latest. July is more likely. And between now and ASCO, possible. But it'll be when it will be. Hopefully, if this drags out past ASCO, we'll get an update of some kind. Give Dave Innes something new to talk about. :)
As to when it will be finalized, or approved, or whatever the heck it's called, I would hope soon after it's submitted, if it hasn't already been submitted. 30 or 60 days afterwards? But will there be FDA comments that require changes to it, or will it be smooth sailing? I think that's what could hold it up, or end the multi-month process in a reasonable time.
I'd like to think September at latest. July is more likely. And between now and ASCO, possible. But it'll be when it will be. Hopefully, if this drags out past ASCO, we'll get an update of some kind. Give Dave Innes something new to talk about. :)
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