Is contained in statement that "AMIC is engaged in discussions with the FDA through the Pre-Submission process, including an in person meeting". That statement confirms the meeting with FDA that the poster earlier said was announced in the meeting to increase shares, but the interesting new information is "Pre-Submission process". That gives us a hint of the timeline until ADMD might, and I repeat might be updating us (because they might not like what they hear and keep it to themselves). The PR doesn't say that they are going to meet with the FDA in the future or have already. But at the point they do the FDA is supposed to get back to them in 75 to 90 days with feedback. BTW, do be in the Pre-Submission process ADMD had to submit a request to use the Pre-Submission process so they have decided on a path of figuring out a path. Also, one of the many situations for which the FDA recommends using the Pre-Sub process is "When preparing a submission for a new device that does not clearly fall within an established regulatory pathway".
So lets start guessing time frames. I am guessing 4 months until Pre-Sub process feed back is obtained (because reading between the lines I don't think they have met yet), then 3 to 9 months for ADMD to do stuff with feedback from FDA (perhaps create new submission, conduct animal animal tests, or human tests), then resubmit and wait (3 months) and then allow for the the usual delays by throwing in 2 more months. That makes it 9 to 15 months until approval. But thats assuming we don't go full PMA. If that happens toss in another year(s) and many millions of dollars. Time to stop watching this closely.
Kayak. When a human trial is determined expect a minimum of a year and easily two years for enough humans to be identified and accepted into the trial, perform the study, analyze the results and prepare them for submission for review by the FDA. Also, add time Pre-trial for ADMD to find, as well as contract, with for a JV for the trial. They will have to demonstrate that their product is as good or better than products currently available. I think this trial will take the longer amount of time I mentioned. #1 it has to meet endpoints of actually stopping and/or eliminating cancerscancers; this will take time with follow up and everything else needed to determine effectiveness. Then #2 they need to demonstrate it does not cause adverse affects in the patient short term at least. They might have to maintain a study medium and long term to determine no adverse health risks develop. This trial could easily need 300 enrolees and will certainly need a medical facility UW MED or similar cancer research centers willing to provide support to the trial.
Do you want to try again on your timeline guess or are sticking to it? :-)
My ideas above are just my opinion and driven mostly through following the pharma sector. Medical device could be easier or more difficult. This thing is class III so I am expecting quite a trial.
From a 2012 analysis "The average review time for PMAs fell from 389 days in 2009 and 354 days in 2010 to 266 days last year." But that is probably after the PMA is submitted, and there are several earlier stages to which you refer. So it is probably 3 to 5 years. But I don't see how this needs to go the PMA route. If it has to go that way I think it will be yet another failure of management. As other's have posted radiological devices are typically class II. If they just need to add a new material or radiation source to the existing definition they should be able to establish it has a similar device. So I will try to remain hopeful that it will not need to go PMA and stick to my 1 to 2 year time frame (during which small animal or human testing may be required).
This is unlikely ever to get FDA approval. Katzaturd in making a paycheck for himself at the expense of moron shareholders. Battelle new this was a extreme longshot when they gave it to a pink sheet loser like ADMD. Its a scam, morons.