NorthWest Biotherapeutics Inc (NWBO)

[franky111]

I know this is a stretch. It seems that the hold on the P3 trial was never explained. There is no FDA form 483 listed anywhere for NWBO. My understanding is that this form should have been filed by the FDA in order to put a hold on the trial. At the very least there should have been a warning letter issued by the FDA to NWBO, for what ever caused there concern. I could not even find record of a warning from the FDA.

The Hold was placed on Aug 21st 2015, I believe that is correct.
On Aug 24th 2015, the FDA issued a warning letter to Rapid Diagnostics, Division of MP Biomedicals, Llc. That between February 19 and March 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in vitro diagnostic devices including the OneStep Myoglobin RapidCard InstaTest. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Because, This inspection revealed that the OneStep Myoglobin RapidCard InstaTest device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The OneStep Myoglobin RapidCard InstaTest device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution in that a notice or other information regarding the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(ii). For a device requiring premarket approval,

What would happen if this piece of equipment was being used at some of the P3 test sites? What if the company(Rapid Diagnostics, Division of MP Biomedicals, Llc) did not want to release this info at all to the public, even after it was corrected? They may not have to release any public info because it was only a warning and it was corrected. Why leave the hold on our trial? I don't know.

I know this is a real stretch.

Here is the link to the FDA warning letter, if anyone cares.

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm459598.htm