Replies to post #426668 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

great info as always Lykiri
thanks

[hope4patients]

Excellent and informative post. Makes me want to add to my share count again :) Thanks!

[Enoch_365]

Lykiri

Are these emails and responses very recent? Of from when the endpoint changes were first noticed months ago?

TIA

[eagle8]

Thank you for sharing Lykiri.

GLTU

[Mionaer1]

Great post Lykiri. Master of DD.

[extrooper]

FDA, Bought and paid by their owners, big pharma.

[MI Dendream]

E ……. …. b … ….. X ….. … n

… W … BOOOM! … … E

… … N … ……. N

…..A … …… .. A …… E

[Bob_LobLaw]

You are the GOAT. Thank you again for sharing your findings

[Dr Bala]

Thanks, Lykiri.

[highwayman4life]

Excellent work Lykiri!!

[The Danish Dude]

Great read Lykiri. Thanks for the update!

[Smokey21]

Great information Lyriki. Thanks for taking the time to find this out. This should squash any FUD on this issue. Good suggestion Ex!!

[Know-Fear]

Thanks, very cool……and “telling” in a “kool” sense.

[exwannabe]

Nothing in your post say anything about the IND change being accepted implying the PEI says the endpoints are good for approval.

I have said many times that the protocol change has been approved by PEI and MHRA. They are responsible for overseeing safe and ethical trial in their countries. They are (or were not at the time) responsible for approval decisions. It would be the EMA would have had to make that call.

[flipper44]

Thanks Lykiri.

[antihama]

Man, Lykiri! That's good stuff!

[pgsd]

Thanks Lykiri, excellent work.

[sukus]

Thanks for the effort Lykiri. Appreciate it.

[hyperopia]

Thanks Lykiri, excellent details!

[Chiugray]

Indisputable. Thanks!

[Nick119]

Great post brother.

[skitahoe]

Lykiri,

Great post.

Frankly it's sad but this is very much like other Govt. departments, like the IRS operate. You can go to the IRS for an opinion on tax laws and follow their advice, but if Tax Court says your filing is incorrect and you owe, it won't matter that you followed the guidance from the IRS in preparing it, you're wrong and you must pay.

I would suspect that the reason so much time was spent before the trial was locked was to work to get as positive an opinion from the FDA as possible. I really believe that if the other regulators approve, the FDA will also approve, the question is, will they work together and do it together, or will each act independently. I believe the BLA will be filed in the near future, but probably not this year. If I'm right the PDUFA date will be in the third quarter of next year, but the decisions could come sooner.

Gary