Replies to post #665564 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

Read this article. Disruptive science doesn't come often. Humira brought Abbvie $200b. Have we seen Abbvie came up with another revolutionary drug like Humira?

Papers and patents are becoming less disruptive over time
https://www.nature.com/articles/s41586-022-05543-x

[beachhyena]

You have absolutely no idea about Linda Powers has setup. You need to do a lot more research about DCVax L and in particular Direct. 7 more years after proving it works on the hardest to treat cancer, you having a laugh.

[The Danish Dude]

Trust me, the FDA just wont take your word for it ;) This is fact.

So you are saying you're left in the dark about MHRA approval under IRP?



Lets ask ChatGBT.

Under IRP in the UK when DCVax-L gets marketing application approved, will
Northwest Biotherapeutics then be able to get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under IRP and witt new short Time horizons for authorisations, set at 60 to 110 days?

Yes, it is possible that Northwest Biotherapeutics could get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland, the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under the IRP and with new short time horizons for authorizations, set at 60 to 110 days. This is because the IRP is a regulatory pathway that allows for the expedited review of innovative therapies that have the potential to address unmet medical needs. The IRP is designed to be more efficient and flexible than traditional regulatory pathways, and it can help to accelerate the availability of new therapies to patients.

In the case of DCVax-L, the IRP could be used to expedite the review of the marketing application for the drug in the UK. Once the marketing application is approved in the UK, Northwest Biotherapeutics could then use the IRP to seek approval for DCVax-L in other countries that participate in the IRP. This could potentially help to shorten the time it takes for DCVax-L to become available to patients in other countries.

Here are some of the factors that could influence whether or not Northwest Biotherapeutics is able to get DCVax-L approved by regulators in other countries under the IRP:

The strength of the scientific evidence supporting the safety and efficacy of DCVax-L
The extent of the unmet medical need for DCVax-L

The willingness of regulators in other countries to participate in the IRP

If Northwest Biotherapeutics is able to get DCVax-L approved by regulators in other countries under the IRP, this could have a significant impact on the availability of the drug to patients worldwide. It could also help to increase Northwest Biotherapeutics' revenue and market share.

[TTsr]

No, no need to sell, not for another 3-5 years. PartnershipS will bring in big $ and pay for trials, but these baskets will not take 7-10 years. You seemingly have all the answers so you should know this. Yesterday - courtesy of readers on Reddit - we saw just a very small fraction of the groundswell of support THAT WILL turn into a tidal wave once NWBOs ENTIRE story reached the masses. With partners, this supposedly ‘old’ board will be fine watching others do the heavy lifting, and if/when they will sell, it will be for the company’s maximum value!

[biosectinvestor]

This is false, that there will need to be trials and more trials to expand beyond GBM. That’s not how it works anymore. The rules are completely different now and all it requires is real world information, and expansion of labels and also insurance coverage is there. Now you do those additional trials so that you can publish and show efficacy.

Read up on the 21st Century Cures Act.

Your speculation about what you think the future holds therefore is not up-to-date.