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10baggerz

04/28/21 3:54 AM

#373014 RE: datafarer #373007

If he hasn’t looked at the data and thinks that the main reason the treatment won’t be approved is the lack of the use of a concurrent control, then I am relieved because the authorization of the use of historical contemporaneous controls by the FDA is a recent development.

If he looks at the data and the FDA guidance on external controls, there is no other conclusion but that FDA approval is a strong probability assuming the primary endpoint is met.

I’ve found that doctors often are extremely dismissive of anything they don’t use in their daily practice, so the fact that he thinks it’s “crap” without even looking at the data is not concerning to me in the slightest.
If it is to you, by all means sell and take your profits.

I’d refer you/him to a knowledgeable oncologist who posts on this board (or to LL’s SNO 2018 presentation):



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VuBru

04/28/21 9:53 AM

#373060 RE: datafarer #373007

Your friend may be basing his negative opinion on historical failures of prior attempts to develop similar vaccines (using different strategies). That opinion may not be unjustified, but it is very unlikely he knows the specifics of the blended data publicly presented in peer review form. This is an under the radar intervention that most expect will fail, but the OS numbers observed to date surely indicate something is working. Nothing is ever guaranteed, but the likelhood that the trial results will represent a total failure is very low. There is a signal in the noise, and they are working hard to show it despite challenges with the "old fashioned" trial design they selected over 12 years ago.
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H2R

04/28/21 9:55 AM

#373062 RE: datafarer #373007

49.1% survival @ 3 years for Methylated Group (131 in trial)

Your friend may have some bad information on the trial.

Best of luck to NWBO, Patients, and Longs!
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Dr Bala

04/28/21 9:59 AM

#373066 RE: datafarer #373007

He needs to talk to LL and Dr. Leia NghiemPhu about why they are using the DCVax-L in their current follow-up trial at UCLA (specifically, the Project I Combo Trial).
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sentiment_stocks

04/28/21 10:15 AM

#373075 RE: datafarer #373007

Is the institution another university and if so, would you be willing to share which one? Did the institution take part in the DCVax-L trial?