Arch Therapeutics Inc (ARTH)

[Minding]

FDA approval:

I've seen a few mentions of the FDA approval process for a 501(k) taking 60 days. To be clear, I have no expertise, but my understanding is that it is much longer. One source told me 9-12 months. Another (https://www.meddeviceonline.com/doc/how-long-does-the-fda-k-review-process-really-take-0001) says:

FDA sets goals to review and respond to 510(k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests. “The 90 day goal set by the FDA should largely be ignored when you are trying to determine how long it will actually take to get your 510(k) reviewed and cleared,” Schorre concluded. Plan on the process taking closer to six months.

The FDA says that by day 60 they conduct a Substantive Review (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#timeline) They also say "The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#decision)";

Perhaps those saying 60 days could document (i.e. provide links) supporting that position.

Having bought and rebought and held all I've bought over the past few years, I of course prefer the 60 days! Knowing may affect some actions I plan to take leading up to approval which I, like everyone here, hope is unimpeded.

Thanks,
Minding