Replies to post #437259 on NorthWest Biotherapeutics Inc (NWBO)

[norisknorewards]

Boom

[Margin Buu]

Excellent! Thanks, Senti.

[hoffmann6383]

good post sentiment. agree that ex's argument doesn't make sense when you look at the facts

[skitahoe]

Senti,

The initial SAP would have been the one established in Clinical Trials at the beginning of the trial. Revising Clinical Trials would update the SAP to what was submitted to the regulators prior to data lock.

In some ways they were rearranging the goals, overall survival was there before, it just wasn't primary. Few trials use OS as the primary goal as it makes the trial substantially longer to get some minimum time for all patients in the trial. I believe that when NWBO recognized that OS was their best shot at approval they knew they were adding years to the length of the trial.

I believe that if the DSMB ever discussed ending the trial early, they could have made a case for overall survival, even if it wasn't the primary judgement criteria at the time. I don't know if this ever happened, but if it did I'd bet it was because they saw many long term survivors in the trial.

Gary

[highwayman4life]

[flipper44]

I either forgot they had no prior SAP, or I just didn’t know. I’m not sure which. At least of late, I’ve been assuming it was modified once in 2019 through 2020, but apparently there was no prior SAP to modify, so they started from scratch, and finished in 2020, it sounds like.

Ex’s thesis is apparently toast.

[The Danish Dude]

Lets not forget Ex’s answer to Senti today.

[eagle8]

Well done sentiment !
Thank you.

Best to you.

[hope4patients]

And there you have it folks. Ex’s theory is eviscerated. Thanks, Senti. :)

[abc1212]

Thanks Senti, that information is massive

Lets see if Ex answers this or just goes quiet

Naysayers have spent many years using the fact that an IA had been done.
Even after Bio said it had been proved in court that one hadn't happened they then tried to say it was done the following year.

This DD dispells all of that rubbish.

Can't thank you enough for this.


Also, loved hope4patients quote
Ex’s theory is eviscerated

There's no coming back from that painful experience :-)

[dmb2]

God bless you sentiment stocks and others who have the patience to address the likes of this poster, because it helps newbies to this investment.

New endpts means there were old endpts and old endpts incl their measurement and analysis, had to be explained prior to trial initiation.

The fact that only placebo patients were restricted post screening hold is another positive clue ignored by this poster.

[MI Dendream]

Thanks for this intel, Senti. If they never had an SAP, you can pretty much assume FDA has had input on the one created after 2018.

On top of what you say, the company has stated multiple times that NO INTERIM EFFICACY ANALYSIS WAS EVER PERFORMED.

The bear thesis is absolute bunk, and by now they know it.

Longs need to ignore stock price and the psychological games they try to play with it.

[Arby2000]

I also recall the head of the DMC issuing a very emphatic statement refuting claims by various bloggers and others that an IA had been conducted and did not show any efficacy.

[learningcurve2020]

The SAP we know about was on the table by mid 2019. But a SAP after the last patient was treated is a big no no for the FDA. I'd bet the FDA had a SAP prior to 2015 and your 2020 submission was for a subgroup. ??


3.9 Analysis method
For each study objective, explicitly describe the statistical method or model, and the assumptions required by the method. Levels of statistical significance (eg, confidence interval and P-value) should also be defined in this section. Secondary or subgroup analyses should also be defined, to avoid post hoc “fishing” for associations should the primary analysis prove not to be statistically significant.

[exwannabe]

You realize that the SAP they submitted to regulators in 2020 ws the first one, right? There was hands down, NO SAP existing for the trial prior to that time. Yet in order to perform an efficacy analysis required an SAP. It's not that it just wasn't mistakenly leaked (by outsiders)... there wasn't one to leak.

I highly doubt there was no earlier SAP. All you have shown was that it was not done as a section of the protocol, not that none existed.

If you are relying on the "will be provided" language, ypu are grasping. The leaked protocols were from prior to an IA. And further, it also says the DMC Charter will be provided. Did they not provide the DMC charter either?

But have it your way. They still could perform an IA as they say additional stat details would be in that DMC charter.

Not ever having created the SAP only makes this trial more of a running clown act.

[pqr]

senti - 2 thumbs up