Imaging Diagnostic Systems (fka IMDS)

[smoke_eater]

How are we going to have FDA approval this year? Please review and tell me how this can happen. I am not saying it is impossible, I am saying it is unlikely.

Steps required.
1. obtain significant funding to pay off taxes, current debt, AND hire FDA consultants.

2. compile data, obtain additional required data, and fill out said application.

3. File Application which can take 90 days, or 280 days, who knows how long to review. But looking at the FDA website 90 days or less is unlikely. Here are the steps, link is at the bottom.

Steps in the PMA Application Process

ODE filing review

OSB statistical review for filing

OC review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).

PMA filing decision

Day-100 Meeting

Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection is conducted for all original PMAs and may be conducted for PMA supplements requesting approval of alternate or additional manufacturing and sterilization facilities.

Bioresearch Monitoring (BIMO) Audit (audit of clinical study data)

Substantive review coordination and completion in areas such as:

Preparation of FDA Summary of Safety and Effectiveness Data (SSED)

Nonclinical Studies
[Microbiological, Toxicological, Immunological, Biocompatibility, Shelf Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue, etc.)]

Clinical Studies

Panel Meeting Decision and Mailing (if panel meeting is appropriate)

Panel Date (if appropriate)

Transcripts Received, Reviewed and Placed in Administrative Record

QS/GMP Clearance

Final Response from OC for GMP/BIMO

Final ODE Decision Memo

Approval Package

, Approval Order, , SSED, Final Draft Labeling

4. Now assuming that is all done (there is a day 100 meeting very early in the list) so I would guess it is the longer time frame. We still have the issue with production and sales.

How do they go from producing a couple a year to producing thousands. It isn't flip a switch and they start showing up. You have to get significant resources and can they make the specialized equipment fast enough....

This is not going to be a quick flip making us all millions, it is a long haul and that is IF the stock doesn't get diluted out.

I am long IMDS and have faith it will do very well as a technology, but success as a technology does NOT equal success as an investment.


FDA Link
FDA Link