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Posted On: 02/07/2020 1:57:28 PM
Post# of 148908
I agree. I added significantly this morning after I thought over the China/IP issue for a bit and came out satisfied.
The BLA issue is more a problem of messaging and expectations than anything, although that's a very, very real issue that NP needs to fix immediately. It's unthinkable that he's still not careful enough with his timelines and pronouncements. However, the only real reason I can think that the FDA would want data from all 585 CD03 patients is a decidedly positive reason, so I'm not altogether upset with the reason for the delay, just the messaging.
The BLA issue is more a problem of messaging and expectations than anything, although that's a very, very real issue that NP needs to fix immediately. It's unthinkable that he's still not careful enough with his timelines and pronouncements. However, the only real reason I can think that the FDA would want data from all 585 CD03 patients is a decidedly positive reason, so I'm not altogether upset with the reason for the delay, just the messaging.
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