There is also the possibility that the FDA is playing for time in an area which, to some extent, is quite new to them -- see the article in @Zenox's original post to the thread.
"As a result, CRLs are regularly used by the FDA in order to “buy time” to review the application. This is evident in the CRLs many companies receive containing bases for holding the application deficient citing issues or guidance documents entirely irrelevant to the application in question. Because even minor changes to the application under the resubmission option in § 314.110(b)(1) will award the FDA at least an additional two months to process the application, plus the 12 months an applicant is allowed to respond to the CRL, such letters are a valuable tool in acquiring additional time to examine the NDA or ANDA and for the FDA to process other applications."
MSB to dispute FDA finding in Type A meeting, page-79
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