Where we at?, page-689

........."These data provide a detailed justification for the clinical development for
iPPS with the dosing regimen of 2 mg/kg twice weekly for 6 weeks of initial therapy."

.......

"The key items addressed in the Type D response submission to the FDA include:
• The minimal effective dose justification.
• Additional nonclinical studies completed to GLP standards to address previously
noted adrenal findings.
• Draft clinical trial protocol.
• Revised safety monitoring and mitigation plan.

Subject to FDA clearance, Paradigm intends to promptly move forward with subject
enrolment into the phase 3 clinical trial (PARA_OA_012) in 2H CY2024......"


2 mg/kg has never been cleared by the FDA. If it was, you can bet your bottom dollar that 2 mg/kg would have been in the dosing study to generate comparable data. Even you would do that.

BTW - you don't submit a new IND, on top of an IND for the same investigation...

MPS trial - failed with no hope of a partner.
Dosing study for OA - failed or as Donna Skerett put it "Did not meet the required performance thresehold"