hey ex u are arguing against ur own position if you’d like I can edit ur contributions before u post LMK if u r interested
Quoting ur post:
ex: 1. Uhm, first the rule does not apply if the company asserts they are planning on filing a BLA for a previously unapproved product.
Answer: IDK but if u r correct the rule is inapplicable so … so what? PS I believe your assertion is incorrect but either way … so what?
ex: 2. Second, the clock starts with the last data collection from a patient, not the data lock. We do not know when that was, but certainly well over a year ago.
pqr: Correct - that date was October 5.
ex: 3. Third, this is the same body of law that LP has violated for years. There is basically no enforcement.
pqr: “Body of law” is a pretty wide statement of ur objection. Honestly IFK what ur talking about. But assuming arguendo u are right - so what? Ur own characterization is that “it doesn’t matter.”
We agree on that! Good evening Tony!