Trimel Pharmaceuticals (TSX:T.TRL
, Stock Forum
) was dealt a body blow Friday when the US Food and Drug Administration (FDA) asked several questions regarding their new drug application (NDA) for their CompleoTRT product.
According to a company news release
sent out Friday, “As part of its review of the NDA and following an internal FDA mid-cycle review meeting, the Company has been asked to clarify several points relating to the analysis of the dosing arms in the CompleoTRT Phase III study and the utilization of certain data from such dosing arms to support the proposed product label.”
“In particular, the FDA has requested an explanation regarding the relative performance of those patients that commenced treatment using a twice-a-day dose and were titrated to a three-times-a-day dose in accordance with the Company's proposed titration scheme.”
To investors hoping for a fast (in FDA terms) approval process, this was clearly a tough hurdle to overcome, as stock in Trimel dropped 46% on the day, plunging $0.345 to $0.405.
Officials at the company state they have not been advised of any delay in the NDA process as a result of the need for extra information, but did say, “it should be noted that the FDA has suggested that the Company may consider seeking approval for a product using only the three-times-a-day dose, but that certain review issues would have to be considered further.”
The company “remains committed to the commercialization of CompleoTRT and will continue to work with the FDA towards obtaining approval.”
“However, there can be no assurances that the Company will not be required to make changes to the NDA for CompleoTRT (including to the proposed labelling or dosage protocol) or that additional clinical data will not be required, and there is no certainty that CompleoTRT will ultimately be approved.”