Replies to post #315824 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Wowww!!!!! Thanks.

[kfa670]

Great DD man!

[marzan]

wow anders another jewel finding next to ATLinsder. Great board we got!

[photonic5]

This is great information. Thank you for sharing.

[Sojourner55]

Sorry Anders, you mean to say the FDA had to approve it first as home country? Wow, that’s great news. Thanks for your efforts.

[Poor Man -]

You’re urberman!

Danke Schoen.

[biosectinvestor]

Excellent work! Awesome!

[Basin Street Blues]

Jeez well done Anders superb info

[abeta]

Also, she confirmed that in the case of NWBO this has been done so by the NHS in the UK and PIE in Germany.

Anders - Thank you for the phone call AND Thank you for advising
this board.

regards

[Biotemptation]

Very nice! Thanks

[Dr Bala]

Additional good news. Thanks.

[abeta]

Please sticky 315824

[Pattyloco]

Bravo

[sukus]

Perfect

[MI Dendream]

Anders, this is huge! Thank you for contacting them. This means that NWBO did indeed get regulatory approval to change the endpoints. Given the exceptional results of the blended, blinded data set, we have an outstanding chance of gaining approval from the EU.

LP pulled another rabbit out of her hat.

[kabunushi]

Excellent way to work the phones, thanks for sharing this info! Definitely a significant confirmation. Another large nail in the coffin of Mr. Shorty and in the hoof of his pet horse Neigh Sayer.

[Chiugray]

Assertiveness. Excellent and thanks!

[learningcurve2020]

If this is true it IS material. Another great reason a publically traded company must hold quarterly cc Q&A.

[H2R]

Excellent DD anders! Thanks for sharing this with us!

Best of luck to Patients, NWBO, and Longs!

[Arby2000]

Thank you anders!

[abc1212]

Great work anders, thanks

[Kam8]

Thanks for your great work

[hankmanhub]

WOW. That is what I have been waiting to hear! The RAs have bought in. This is the first clear statement that this must have happened. This is great news! Thanks Anders for this very valuable information.

I just got off the phone with the clinical trial regulation department EMA.


She confirmed that NO changes to clinicaltrialsregister.eu can be made directly by the sponsor. She told me that indeed only approved changes such as endpoints are submitted to the clinicaltrialsregister.eu IF the national health organizations in the specific countries have allowed and approved such.

In the case of NWBO she confirmed that this has been recently done so.
Also, she confirmed that in the case of NWBO this has been done so by the NHS in the UK and PIE in Germany.

[ATLnsider]

Thanks anders2211. It sounds like we got buy-in from all 4 RAs (USA, UK, Germany & Canada).

Edit: Upon further reading, it appears you are confirming buy-in from U.K. & Germany only Thanks for the information! This is great news.

[Fosco1]

Excellent Anders, thank you

So :

This is recent and still needs to be announced in the incoming days imho as this is material info

In my opinion PPS will pop fairly once they announce officially the good news

Why haven't they update CT site and announced that the FDA had agreed for the change ? There are deadlines to follow

[eagle8]

Well done anders!

Thanks for the good work you did.

Best to you.

[sentiment_stocks]

Best post of the 350 posts thus far today!

Thanks for taking the additional steps to prove what we were hoping and thinking. :)

[Hbpainter]

Wow!

[xoma4578]

Great work Anders. Have a great weekend.

[Doc logic]

anders2211,

Great job with this follow up. Took a while to get you turned toward the positive but sure am glad you stuck around long enough to see the light start to rise over the horizon of the “new day”. Best wishes.

[br8k0ut]

Anders coming through in the clutch! Thank you!!!

[aperture007]

Anders, Just outstanding DD! I appreciate you going the extra mile to dig up this information. Looking forward to more of your posts.

[tryn2]

So we have approvals for changing trial primary and secondary endpoints for DCVax-L from England, Germany, and the European Union, and currently we are unsure about those approvals in the USA and Canada... is that correct...???

[Sub Atomic master]

Wowzaaaa

[X Master]

If I would have saw this post I would have bought today!

[fluteman]

Anders2211, thank you for sharing!

[ilovetech]

anders2211 - Bravo!

[fluteman]

Anders, wow! Awesome share!

[ilovetech]

anders2211 - Ty!! IMO, the reply should be memorized to use at will, with its specificity to squash misinformation about any so called, "ad hoc" endpoint changes. Like sending that correspondence to the authors of the error ridden article (s).

ILT