Spectral Medical Gives Update on Recent FDA Meeting

Spectral Medical (TSX:EDT) provided an update to shareholders regarding its meeting with the US Food and Drug Administration (FDA) on its PMA application for Toraymyxin.
As quoted in the press release:

The meeting consisted of a general discussion of issues identified by the FDA after the first 100 days of regulatory review and suggestions for clarification of those issues. The Company committed to a timely response to the FDA’s questions, which is expected to occur during the month of November 2017.The next review cycle in the process is expected to begin after answers are provided by the Company and are deemed by the FDA to be complete. Generally, FDA guidelines suggest a 180-day anticipated timeframe for completion of review, excluding time required by the Company to satisfactorily respond to any issues.
“We had a productive discussion with the FDA review team, committed to answer the FDA’s questions in a complete and expeditious manner and reaffirmed that we will work diligently with the FDA to address all aspects of their review. The Company remains focused on making a beneficial treatment for endotoxemic septic shock available for a specific group of patients where no other therapy exists”, said Dr. Paul Walker, President and CEO of Spectral.

Click here to read the full press release.

Source: www.marketwired.com