Replies to post #162687 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I knew you'd chime in on that one. Dr. Liau is her contact. Dr. Liau does INDs. The likelihood is we are waiting for official commercial batches to be produced, imo, and Dr. Liau probably has to wait now. I could be wrong. You'd think Dr. Liau or Ms. Goldman would otherwise tell them if that was available, so I think it's probably important, if DCVax-L is successful, that it get approved immediately. Don't you?

[biosectinvestor]

I doubt, operating on one-offs, that they can meet the level of demand they are getting for compassionate use. Just my impression from that exchange. It likely costs a lot more than what they are charging to scale up to the level they are now for one-off production runs when they are not scaled, funded and ready yet to do commercial, daily production.

I'm sure it is frustrating. But Cancer is not a rare disease. Just the posts alone of supporters of the company on Twitter daily are likely causing all kinds of inquiries they can't meet. They need to get to market, but they also need to meet the requirements to get approved and to get paid ultimately, and survive competition, which will likely be along in a few years and well funded once they succeed.

Lots of tough decisions.

[sentiment_stocks]

Perhaps Linda Liau would be willing to do that. But it would entail her having to fill out FDA forms 1571 and 1572 which entail this...

The IND should include the following information:

1. A statement that this is a request for an individual patient IND for treatment use
You will need to specify whether it is an emergency IND or individual patient IND. This statement should be at the top of the correspondence and on the mailing cover.

2. A brief clinical history of the patient including:
When submitting your request you will need to provide the FDA with the following information about your patient:
the diagnosis
the disease status
prior therapy
response to prior therapy
the rationale for requesting the proposed treatment, including a list of available therapeutic options that would ordinarily be tried before the investigational drug or an explanation of why use of the investigational drug is preferable to use of available therapeutic options

3. The proposed treatment plan including:
When submitting your request you will need to provide the FDA with the following information about your patient:
the dose
route
planned duration
monitoring procedures
modifications (e.g. dose reduction or treatment delay) for toxicity.
Reference a published protocol or journal article if appropriate.

4. Include the chemistry, manufacturing, and controls information and pharmacology and toxicology information:
In your application you will need to include a description of the manufacturing facility.
The requirement for this information may be met by providing a Letter of Authorization (LOA) to refer to this information if it has been previously submitted to FDA (for example, to an existing IND or NDA).

The treating physician should contact the sponsor of the previously submitted information for such authorization and letter.

The letter of authorization should include relevant identifying information, such as the sponsor’s relevant application (e.g., IND) number.

5. Provide a copy of the informed consent statement:
When you submit your request you will need to provide a statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment.
In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.

6. Submit the Physician Investigator Qualification Statement:
You will need to provide the FDA with the a statement that specifies the training, experience, and licensure of the treating physician. This can usually be found on the the first two pages of a Curriculum Vitae typically contain this information and are usually sufficient.

7. Fill out Forms 1571 and 1572
Below is the link to form 1571
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf

And here's the pdf for the instructions to fill out form 1571.
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM182850.pdf

Below is the link to form 1572
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf

Now how long will it take for Linda Liau to fill out that form? At least a week, given that she's a busy neurosurgeon. Plus she has to obtain all the information in step 4 from NWBO. Then after it's received by the FDA, it would take another 30 days before the treatment can begin (not a few days as some have indicated - unless it's an emergency). And while 99% of all single patient expanded access requests are approved (according to the FDA website), they could also contact the physician to request more information or clarification which could also add more time to an approval of a single patient IND.

The doctor requesting such an IND must also find a facility where they can administer the treatment, and an IRB to oversee this single patient arm trial. That would likely not be difficult for Linda Liau; however for some physicians, this might not be so easy.

And after all this, you've got to get NWBO, for whom cash is a very precious commodity right now, to turn on the manufacturing process at Memphis for a single person vaccine. And then shut it down.

It's unfortunate, but a single person trial is no easy undertaking. And it's expensive. Do you want NWBO shouldering the cost for all of this with what little cash they have? Or perhaps they could approach Sabby or Roth or IntraCoastal for another toxic funding to raise the money?

Really?