NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

[GlobeCitizen]

 

[GlobeCitizen]

For record regarding endpoint changes

Eu site: https://www.clinicaltrialsregister.eu/ctr-search/search?query=DCVAX

from which UK:

Clinical Trials Register

E.5 End points
E.5.1	Primary end point(s)	The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.
E.5.1.1	Timepoint(s) of evaluation of this end point	October 2020
E.5.2	Secondary end point(s)	The first secondary endpoint is overall survival (OS) compared between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM. The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221. The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221. The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221. The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
E.5.2.1	Timepoint(s) of evaluation of this end point	October 2020

It seems German site has not updated yet:

Clinical Trials Register

changes confirmed by Anders2211 over in ihub:

 

[GlobeCitizen]

The market has continually gained confidence on a successful trial of which topline data is about to release any day now, after digesting the newly updated FDA guideline Demonstrating Substantial Evidence of Effectiveness for Drugs, and newly found endpoint change in EU clinicaltrial register posted previously in this thread, which fits well with new FDA guideline.

 

[GlobeCitizen]

More positive tidbit of information:

 

[GlobeCitizen]

 

[云霞]

涨这么急,还敢追吗?

 

[GlobeCitizen]

这样说吧，试验结果很快就要出来了。如果结果如预期般的好或者更好， 那么股价将进一步上涨。根据同比比较，股价将上涨到至少五至三十美元，取决于具体结果。另外的可能还有和大医药公司合作或者被其收购，股价也可进一步上涨。

但是，如果试验结果不如预期或者失败，那么股价将急剧下降，甚至可能降到几美分。

根据最近的消息 ，试验失败的可能性基本为零（你可根据上面提供的信息做些DD，即可得出此结论）。这就是为什么市场最近有如此正面的反应。

说到底，自己的钱自己说了算。 【不经常写中文，等有时间我再用英文解释】

 

[Henri]

Is DCVAX-L designed like a personalied vaccine and a shot is required every year . My understand is phase 3 trial patients are getting shots every 6 month.

 

[GlobeCitizen]

Yes DCVax-L is designed and used as personalized vaccine. The administration of the vaccine is as follows:

Drug: Dendritic cell immunotherapy
Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.

ClinicalTrials.gov

clinicaltrials.gov

[note: the site has not been updated since 2016.

 

[Henri]

Thanks for the info.
I was hoping DCVAX will require an annual treatment like the flu vaccine. Then it will be a perfect business model.

 

[Henri]

In theory DCVax-L is applicable to all solid tumors? And NWBO needs to do trials for each different solid tumors?

 

[Henri]

Or all non GBM solid tumors should use DCVAx Direct ?

 

[GlobeCitizen]

Thanks for the info.
I was hoping DCVAX will require an annual treatment like the flu vaccine. Then it will be a perfect business model.

Yes, if that were the case, it will from commercial point of view. The vaccine is made from patient's tumor (from a gram to a few grams) and DCs extracted from patient's blood, which will be enough for 2 to 3 years of use. After that, it is believed the patient will acquire immunity so no further vaccine administration is needed.

 

[GlobeCitizen]

In theory DCVax-L is applicable to all solid tumors? And NWBO needs to do trials for each different solid tumors?

yes it is. Not necessarily a full-length trial is required. It's called label extension. Combined with well defined bimarkers, the trial may be shortened to within one year.

 

[GlobeCitizen]

Or all non GBM solid tumors should use DCVAx Direct ?

No. DCVax-L is applied to all operable solid tumors while DCVax-D is applicable to all inoperable solid tumors.