What type of FDA approval are your other stocks seeking ? I understand new drugs and therapeutic treatments can be a longer process than diagnostic devices.
Remember the HF product has been clinically validated via the St. Vincent’s Institute of Medical Research (“SVI”) (refer ASXannouncement: 21 May 2024), and the NIL-CHF Study The University of Notre Dame, Fremantle,for its novel AI-algorithm as a heart failure decision support tool. (see also ASX announcement 24 December 2024)
I understand part of the purpose of the pre-submission meeting with the US FDA is to define the clinical validation study protocol required for the application which should alleviate the guess work.
The AS FDA clearance process was more or less on track with what the company advised. Can't see why HF would be any different unless there is something about it the FDA don't agree with.
This is just my understanding. Good Luck.
EIQ Price at posting:
25.0¢ Sentiment: Hold Disclosure: Held
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