Spectral Medical (EDT.TO) said Friday that while the US Food and Drug Administration had identified deficiencies in its premarket approval application for Toraymyxin, this will not "materially" change the regulatory timeline.
Toraymyxin, or PMX, is being developed as a treatment for patients suffering from septic shock.
The FDA had provided Spectral with a deficiency letter several days before the in-person 100-day meeting to review the application. While the letter identified a number of items requiring "additional information, analyses, testing and clarification", it did not request an additional clinical trial, Spectral said.
Spectral is incorporating FDA's feedback and is finalizing the associated work plan and timing. The company does not currently expect the additional activities to result in a material change to its overall regulatory timeline.
Spectral shares were last seen up CA$0.01 at CA$1.27, on the Toronto Stock Exchange.
Price: $1.27, Change: $+0.01, Percent Change: +0.79%