NP can't "force" a CRO to submit an incomplete BLA
Post# of 148054
(Total Views: 451)
Posted On: 11/04/2021 5:29:20 PM
Re: craigakess #109746
NP can't "force" a CRO to submit an incomplete BLA. Amarex may have been receiving pressure from NP, and for very good reason, but they and they alone made the decision to submit the incomplete BLA - not NP.
Did I understand you correctly to say emails can now supersede signed contracts in court? I'm not a lawyer but I find that very hard to believe. Yes, emails can be used as evidence in court, but I can't believe they can supersede contracts between two parties. If that was true, contracts wouldn't be worth the paper they're written on.
Did I understand you correctly to say emails can now supersede signed contracts in court? I'm not a lawyer but I find that very hard to believe. Yes, emails can be used as evidence in court, but I can't believe they can supersede contracts between two parties. If that was true, contracts wouldn't be worth the paper they're written on.
Quote:
If the data wasn't in the BLA after 18 months (and we don't know why that might be just yet), it is OK for NP to force them to submit an incomplete BLA and annoy the FDA instead of claiming breach of contract and suing Amarex?/quote]
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