Replies to post #246750 on NorthWest Biotherapeutics Inc (NWBO)

[VuBru]

Umibe - FWIW - We are importing a noninvasive assessment device from Canada for a research study, which has been imported without problems previously. We submitted for FDA clearance which was by rule supposed to be a 30 day review. After 30 days, we got a notice that they wanted to do extra review and changed the deadline to 90 more days. Arbitrary and unwarranted --- nothing happens fast at the FDA. I have consulted with a company doing an FDA regulated study, and the FDA stats person did actually give input. I agree there will be no official "This is perfect" from the FDA though