Replies to post #692409 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

Thanks, Doc logic

That's not a good news for Merck. This could make slim Merck's hope of extending its keytruda patent.
No wonder Merck has been slow in releasing the top-line-data on this trial. Roche filed the approval for its SC Tecetriq within nine months of finishing enrollment. Both BMS and Roche adopted the same technology to speed up the process of the drug going into blood vessel. Merck used its own technology.

[dstock07734]

Doc,
One more question. Since the results are lackluster, should Merck have the PR on the trial after the close of the market today so that the investors have the weekend to digest the news? I wonder if there could be some great news we can expect from Merck, for instance, the paper on the combo trial.

[eagle8]

Thank you Doclogic for the nice short summary.

" All cause mortality was 5%+ more with subcutaneous administration vs traditional IV. Not really something being hoped for when doing the study. OS not reported nor PFS ".

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174444064


GLTU

[exwannabe]

All cause mortality was 5%+ more with subcutaneous administration vs traditional IV. Not really something being hoped for when doing the study. OS not reported nor PFS. Best wishes.

This was primarily a PDPK and safety study to demonstrate that the amount of Keytruda delivered over time was about the same as with the old formulation. Once that is established it can be assumed the drug works the same.

As such, the primary endpoint would be available fairly quickly, before the PFS/OS data had matured. The OS, PFS and a few other secondary endpoints will be available later. When it is available it will be compared on a non-inferiority basis. What that means is they will hopefully show the OS and PFS is "about the same" between the two. That means the final numbers could well come in a bit worse (or better) than the existing formulation. It means nothing as log as they are close.

Note that the FDA (and other RAs) will look at the most current data for ongoing OS (and other such endpoints). They are not restricted to the primary analysis.