SUDA Pharmaceuticals (ASX:SUD) says it has received a preliminary notice of denial for marketing approval of its ArTiMist oral spray.
The company said the preliminary notice comes as a result of a process to obtain approval to market the ArTiMist oral spray in Australia.
"The process was commenced nearly 24 months ago during which neither SUDA nor its regulatory advisors received any indication that the process would not be successful," said the company in a statement.
"The preliminary notice was provided to SUDA as a copy of the resolution of the Advisory Committee of Medicines (ACM), which provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration.
"SUDA’s regulatory advisors have explained that whilst the resolution has been received, it does not form part of the TGA’s milestones for the evaluation of prescription medicines, and we will still need to wait for the official Delegate’s letter before we can assess the decision in detail and determine the next steps. The letter is expected in mid-May."
The company said it will review the letter with its advisers and "determine the appropriate actions to be taken."
"SUDA has been informed that there is a process that will allow SUDA to appeal the decision," it said.
According to CEO Mr Stephen Carter, “We are very surprised by the decision of the ACM, especially as the various TGA reviewers had all recommended the product for approval. We still believe that ArTiMist has a role in the global fight against malaria and SUDA will now take time to review the reasons for the ACM decision and determine the actions to be taken.”