Replies to post #662568 on NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Welcome 👍🏻 Possible.

https://threadreaderapp.com/thread/1743353786050007120.html

[Bill B]

The IRP route was implemented on 1 January this year and I believe someone posted a while back that DI said we were proceeding under the 150 day route.

[jesster64]

It's possible, but why not just come out and say it in PR? Instead they blame some key personnel for being unavailable for 2 weeks

[manibiotech]

Well they said key consultants were not available . You are putting words in their mouth to satisfy your assumption

[Doc logic]

ROS-CH,

Welcome to the board. The chatter during this waiting period is going to seem like nails on a chalkboard at times; ). Hope you can take it in stride and thanks for chiming in. As you can tell we are mostly all getting anxious to see this get to patients even though some seem to be claiming the treatment does not work based on their financial motives. Best wishes.

[dstock07734]

Well, it could be.

As I mentioned before, if you read Dr. Liau's publications, you can see that she always cites the latest publications in GBM field. But if you read the JAMA paper, you can see from the data lock of Oct. 2020 to the publication of the JAMA paper no new publications were cited from this time interval except one about the terminology and the FDA publication on ECA with Donna Riveria as one of the coauthors. My conjecture is that the paper was ready for publication after the data lock. But LP had to wait for something else to be ready. That's why I suggest the longs pay special attention to any massive construction of biologic facilities from BPs after the data lock.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[exwannabe]

Could it be that the delay was due to the incorporation of these new IRP-Procedures and that NWBO's MAA is now running under those principles ?

Nope. To be being reviewed under the IRP process the drug has to be already approved by another RA.

Welcome to the team though. DI would be proud of you.

[dstock07734]

Here is the 10Q on November 9, 2022 in which we have the following

As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000141057822003073/nwbo-20220930x10q.htm

When did NWBO get the official notice on the acceptance of the JAMA paper? August 27, 2022. Keep in mind this is the official acceptance date. The informal one sent to the authors most likely would be two weeks earlier which could be the mid-August. You see my point?

[dstock07734]

There are many mysteries that could be related to DCVax-L.

For instance, the team of Battelle, AmplifyBio and Andelyn Biosciences was awarded $149 contract from NIH for "Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders". The contract was awarded in September 2022. Why did they release PR in January 2023 which was three months later? It doesn't make sense.

https://www.battelle.org/insights/newsroom/press-release-details/battelle-amplifybio-andelyn-biosciences-win-research-contract-for-national-institute-of-neurological-disorders-and-stroke


https://www.highergov.com/idv/75N95022D00021/