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pqr

08/09/21 7:52 PM

#394587 RE: exwannabe #394493

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!

pqr

08/09/21 7:55 PM

#394589 RE: exwannabe #394493

Oops I gotta stop trying to reply on phone I can’t see the whole message.

“Good Luck to U”

flipper44

08/09/21 7:59 PM

#394590 RE: exwannabe #394493

Not well over a year ago. Final data was recovered by August 19, 2020.. So the last patient data recovered was more recent than you think. That’s just a little less than a year ago.