MSB to dispute FDA finding in Type A meeting, page-312

Well I found this part of the document very interesting.....thoughts?

V. How Do I Overcome the Deficiencies in my CRL?

"The FDA is empowered to waive “any criteria of an adequate and well-controlled study” if an adequate substitute is offered or if compliance with the requirement is unnecessary or impossible.25 Some applicants cure deficiencies by presenting colorable arguments that the FDA’s requirements were impractical or unnecessary. The FDA may grant a waiver if it finds the applicant’s compliance with the requirement is not necessary or not achievable, the applicant has satisfied the requirement through an acceptable alternative, or “[t]he applicant’s submission otherwise justifies a waiver.” While the FDA does not dispense waivers lightly, they remain a potential strategy to overcome certain deficiencies."

Something tells me the FDA did not take this into account when processing the application.