May 23, 2018 / 5:11 AM / 6 months ago

BRIEF-Cosmo Pharmaceuticals Receives Complete Response Letter From FDA On Methylene Blue MMX NDA

May 23 (Reuters) - COSMO PHARMACEUTICALS NV:

* RECEIVES COMPLETE RESPONSE LETTER FROM FDA ON METHYLENE BLUE MMX NDA

* FDA DID NOT RAISE ANY SAFETY OR MANUFACTURING CONCERN

* COSMO PHARMACEUTICALS - FDA DETERMINED IT CAN’T APPROVE NDA IN ITS PRESENT FORM, PROVIDES RECOMMENDATIONS NEEDED FOR RESUBMISSION

* DOES NOT EXPECT ITS GUIDANCE FOR 2018 TO CHANGE AT THIS POINT IN TIME

* FDA IDENTIFIED UNSPECIFIED DEFICIENCIES THAT PRECLUDE CONTINUATION OF DISCUSSION OF LABELING AND POST-MARKETING REQUIREMENT/COMMITMENTS

* COSMO PHARMACEUTICALS THERE MIGHT NOT BE METHYLENE BLUE MMX REVENUES IN THIS YEAR, THERE ALSO WON’T BE ASSOCIATED PRODUCT LAUNCH AND SALES FORCE COSTS

* COSMO PHARMACEUTICALS - BELIEVES CONCERNS RAISED BY FDA ARE FULLY ADDRESSABLE, WILL WORK TO HAVE MEETING WITH FDA AS QUICK AS POSSIBLE Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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