We dont know what FDA are asking of painchek so its anybodys guess. The average time from submission to approval sits between 300 and 400 days. September would be around 300 days.
But apparently FDA have "committed" to a response time of 75 days. I've invested in multiple FDA stocks. Seldom are they early. 13th September 2025 key date.
We've had an extensive 12 month clinical trial in the US with glowing reports from the facilitators. TGA and CE approved. A footprint in Australia, New Zealand, Uk and canada. 3 meetings with FDA face to face. You'd think that would be enough but the delays are a concern.
PCK Price at posting:
3.5¢ Sentiment: Hold Disclosure: Held
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