Monday, August 02, 2010 10:38:54 PM
I own a little over 100,000 shares of IMGG at avg price of 58. I began reading this board when IMGG started to behave so contrary to what (my) logic would dictate - shortly before April's version of "final" submission. I was hoping to gain from the insight of others more serious and knowledgable than I. On the rare occasion, I have; but more often than not, this board seems to be a place for personalities to clash, bashers to bash and be bashed, and for the faithful to express their unfounded but unshakeable belief in Dean Janes.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm
The above link is the location of the 510(k) Status Program descripton which says in part that "...Submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, FDA 3541, and fax it to the CDRH office identified on the form. Within three working days after a status request is received, CDRH will send the submitter a fax that includes:
* The ODE or OIVD division or branch to which the 510(k) is assigned;
* The last action, and date of action, that ODE or OIVD has taken regarding the 510(k);
* The position of the 510(k) in the reviewer's queue; and
* The average review time for the division or branch."
I don't read every post and I don't follow particular posters so I intend no offense to you, BigO. I don't think that my knowing why we haven't (or can't) be kept informed to this degree will change the end result of my investment in IMGG. I am still hoping for the best. But I find it interesting considering the months and months of nothing but mystery and non-information regarding the application, that we know so little about the status of our application.
Even this tiny bit of research and curiosity has jeopardized my claim as the world's laziest investor so I will leave it to someone more ambitious/serious to make the call.
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