Replies to post #16231 on Bioelectronics Corp (BIEL)

[BANKERB]

It is also possible that the FDA is meeting to discuss or approve one or more applications and they currently don't have any new information until the meeting or review.

Banker

[Dubb10]

From the FDA website regarding the 510(k) process:

Decision Letter Issued

The decision letter will be mailed and faxed, if a fax number has been provided, to the submitter upon receipt of the completed 510(k) from the reviewing division. The Document Mail Center staff will enter the final decision into the database and prepare the complete 510(k) file for electronic imaging. After completion of electronic imaging, and back-up microfilming, the original 510(k) files are destroyed.

FDA Requests for Additional Information

When the reviewer needs additional information to complete the review, he or she will either telephone the submitter with a simple request or prepare a deficiency letter which will detail the additional information needed. In the latter case, while the reviewer is waiting for the additional information, the submission is placed on "hold" and is not considered to be under active review.

The item in bold suggests while the reviewer contacted Biel and asked for additional info/clarification, the application was still under active review and would not result in a further delay. Since no deficiency letter has been issued, that we know of, that is good news as far as hearing news soon. Whether or not that news is good or bad remains to be seen. Hopefully good news soon.