Cipher Pharmaceuticals Inc T.CPH

Alternate Symbol(s): CPHRF

Healthcare

Cipher Pharmaceuticals Inc. is a Canada-based specialty pharmaceutical company with a diversified portfolio of commercial and early to late-stage products. The Company acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the United States and South America. Its Dermatology products include Actikerall, Epuris, Ozanex and Vaniqa. Its Hospital Acute Care products include Aggrastat and Brinavess. Its Out-Licensed products include Absorica, ConZip and Lipofen. The Company is also focused on building a portfolio of prescription medicines that serve unmet medical needs. The Company's product pipeline development programs including MOB-015, DTR-001, and CF-101. The Company's subsidiaries include Cipher US Holdings Inc., Cipher US Holdco LLC, and Cipher Pharmaceuticals US LLC.

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Cipher Pharmaceuticals Inc > Cipher Partner, Moberg Pharma Announces Approval for MOB-015

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Comment by drewmumawon Jul 21, 2023 10:51am

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Post# 35551451

RE:Cipher Partner, Moberg Pharma Announces Approval for MOB-015

I find it a bit odd that the nail whitening issue requires an additional phase 3 trial to gain approval in the US and Canada, but the European Union approved it regardless.

The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union.

Are the US and Canada more stringent in their requirements? Or does Moberg just plan on rolling out the product in the European Union despite the nail whitening issue?

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