Nader said the BLA for 350mg was COMPLETE 2 years
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Posted On: 11/02/2020 6:40:28 PM
Re: ClosetInvestor #64046
Nader said the BLA for 350mg was COMPLETE 2 years ago. Highly unlikely doesn’t wash for me. My thought is, it is in sections in PDF format and all sections are together for the 700mg BLA submission the FDA slow walked us on to delay us. It was and is ready and might just need a professional touch up of format to cater to the different dose size.
You can pull the unnecessary information that doesn’t apply to the 350mg dose and you have everything you needed all sitting there waiting to be sent via PDF. Not that you couldn’t include unnecessary information. But why would you?
You have the new ace science officer review it last week and whaaaa Laaaa! It’s sent and filed. To me it’s not that far of a stretch. You make it happen.
You can pull the unnecessary information that doesn’t apply to the 350mg dose and you have everything you needed all sitting there waiting to be sent via PDF. Not that you couldn’t include unnecessary information. But why would you?
You have the new ace science officer review it last week and whaaaa Laaaa! It’s sent and filed. To me it’s not that far of a stretch. You make it happen.
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