Acerus Pharmaceuticals Corporation - President and CEO, Ed Gudaitis
President and CEO, Ed Gudaitis
Source: The Wall Street Analyzer
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  • Acerus Pharmaceuticals Corporation (TSX:ASP) has received a Notice of Deficiency from Health Canada regarding the approval of its avanafil drug
  • As a result, the company has 90 days to provide Health Canada’s requested information regarding the drug
  • Avanafil is a proposed erectile dysfunction drug, which was recently withdrawn from European approval processes due to insufficient clinical trials
  • Once the company submits Health Canada’s requested information, The New Drug Submission process can recommence but could take up to 360 days 
  • Acerus Pharmaceuticals Corporation (ASP) is down 14.29 per cent, with shares trading at C$0.06 and a market cap of $60.63 million. 

Acerus Pharmaceuticals Corporation (TSX:ASP) has received a Notice of Deficiency from Health Canada, regarding the approval of its avanafil drug.

As a result, drug’s approval process has been halted until Acerus can provide further information about the drug. The exact nature of the information Health Canada requested has not been disclosed to the public.

Acreaus now has 90 days to submit the information for Health Canada’s consideration, or risk failing the drug’s approval. If the information is successfully received, The New Drug Submission process can recommence but may take up to a further 360 days.

Avanafil is a proposed erectile dysfunction remedy and is awaiting Health Canada’s approval before it can be made available to the public.

The company recently withdrew the drug from consideration in Europe, after health authorities requested further studies be completed. Once these studies are completed, Acerus plans to resubmit the drug for European approval.

Acreus specialises in sexual health drugs and has already gained approval for a testosterone replacement drug called Natesto.

The company is also developing three drugs related to women’s sexual health, but avanafil is the first of its pipeline drugs to reach the submission process.

Ed Gudaitis, President and CEO of Acerus, is disappointed with Health Canada’s latest decision. 

 “We will be working closely with Metuchen Pharmaceuticals LLC, the licensor of the product, to assess the pathway required to address the deficiency noted by Health Canada and we will provide more information as it becomes available,” he said.

Acerus Pharmaceuticals Corporation (ASP) is down 14.29 per cent, with shares trading for C$0.06 at 10:17am EST.

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