New Valuation $0.65 To $0.80, page-22

Submission of an additional data package of approximately 1700 pages post initial IDE application in unquestionably a direct response to FDA disapproval of the initial application. We'd have heard about an approval or conditional approval by now.

Per FDA regulatory process, a disapproval notification, complete with reasons, would have been communicated to the company within 30 calendar days of FDA receipt of the IDE application. Based on an application date of 10 Dec, 2015 (per OSL ANN), a disapproval notification would have been received by the company at latest in January 2016. In time for Feb responses to be prepared.

"Seeking" a face-to-face meeting at this time indicates the company's February responses (per OSL ANN) to the FDA's disapproval notification have been further rejected, and is likely at FDA's suggestion/recommendation. A clear case of back to the drawing board OncoSil.

For those with any interest applicable FDA regulations are included below. For those with questions, OSL CEO Denial Kenny is your man.

http://www.fda.gov/MedicalDevices/D...vestigationalDeviceExemptionIDE/ucm046164.htm
Upon receipt of an IDE application, sponsors are notified via email of the date that FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16

http://www.fda.gov/MedicalDevices/D...vestigationalDeviceExemptionIDE/ucm046706.htm
The sponsor must demonstrate in the IDE application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.