Replies to post #729255 on NorthWest Biotherapeutics Inc (NWBO)

[Hopeforthefuture3]

The very simple solution is for NWBO to apply for the BLA in the USA - as LP said (RA applicationS) at the Dec 2022 ASM
Do this and problem solved - based on the assumption of approval

[learningcurve2020]

They should bring back the Concord for this.  

[Doc logic]

exwannabe,

That “selling” is by the person or entity receiving it as in an importer to sell to a third party. FDA does not control the sale of the product outside of the US which is then imported for personal use when the exceptions for use as defined are in play. L meets the requirements. Best wishes.

[XMaster2023]

Ex your wrong. However, worst case scenario would be to export the tumor tissue to London (from anywhere) have Advent make the vaccine then the patient goes to London to receive the vaccine. If you have GBM it’s worth it.

[iclight]

Do you guys really think that all anybody needs to do to avoid the need for FDA approval is to set up an ex-US operation? Seriously?

I hear they're gonna skip the FDA and build DCVax clinics on Indian reservations.

[DocLee]

Personal import of DCVax-L into the USA - ChatGPT has this take on it:

Can a US resident legally purchase abroad and legally import into the USA a medication which has not yet been approved by the FDA if the medication is for the resident's use only and is not a banned substance?

ChatGPT said:
"Yes, under certain conditions, a U.S. resident may be able to import an unapproved medication for personal use. The FDA has a "personal importation policy" that allows individuals to bring small quantities of certain unapproved drugs into the U.S. if the drug meets specific criteria. However, this policy is not a right but rather an exercise of enforcement discretion, meaning the FDA can choose whether or not to enforce the ban on the importation of the unapproved drug.

Here are some important points about the policy:
1] Intended for Serious Conditions: The medication must be intended to treat a serious condition, and there should generally be no FDA-approved treatment available domestically for the condition.

2] No Promotion of Medication: The medication must not pose an unreasonable risk, and it should not be promoted to U.S. consumers. The FDA discourages importation of foreign drugs by U.S. consumers for personal use, primarily to avoid risks related to safety and effectiveness.

3] Quantity Limit: Importation is usually limited to a three-month supply for personal use.

4] Personal Use Declaration: The individual importing the drug should have a valid prescription or documentation indicating it is intended for personal use.

5] Customs May Deny Entry: Even if these conditions are met, the U.S. Customs and Border Protection (CBP) can still detain or deny entry to the medication. They may require the importer to show documentation, such as a doctor’s note explaining the necessity of the treatment.

6] Not a Controlled or Banned Substance: The medication should not be classified as a controlled substance in the U.S. and should not be one that the FDA has banned due to safety concerns.

So, while there is a pathway to import unapproved medication for personal use, it carries some risks, and U.S. authorities have the discretion to allow or deny the importation."