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Msg  47563 of 48329  at  8/15/2022 12:37:51 PM  by

ashtonb22


 In response to msg 47560 by  noluckrequired
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Re: Timeline

 "I thin phoebe said CRMD had to do nothing so I assumed the application resumes from where it left off once the CMO and heparin supplier correct the deficiencies."
 
So what do you make of Joe saying: 
"While CorMedix works with the CMO to resolve the deficiencies and resubmit the NDA" 
 
Frankly, that makes sense.  CRMD has to let the FDA know when the corrections have been made.  Also, even with a Class 1, the 2 month deadline has to run from resubmission which means they have to resubmit.  My interpretation of Phoebe's statement is that no changes had to be made to the NDA submission so they just resubmit the same NDA when the corrections have been made.  So I think we will know when that 2 month deadline time period starts assuming Class 1.  JMO. 


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