Replies to post #347 on Vascular Biogenics Ltd (VBLT)

[davidal66]

Maybe, but isn't a common biotech to move to phase III with dubious data. Look at Gale. Look at PPHM peregrine.... both had dubious data, both moved to phase III. All an SPA means is the FDA buys off on the agreed on endpoints for approval... i.e. 12 months overall surveil number of n compared to control arm of m, but it doesn't mean it believes it will work. I think this is a very common biotech mistake that I've made.... moving a drug to phase III says nothing about the drugs efficacy or what the FDA believes. It is a companies decision to move into phase III. The FDA doesn't care about efficacy until AFTER the phase III.

How many companies tout orphan drug status, SPA, phase III, fast track status...ect...ect...ect... but they have nothing to do with the drugs efficacy or promise, one way or another.

[davidal66]

I'm back in, upped my position from before. It's a gamble, but the payoff may be the biggest in biotech if they crack the glioblastoma nut. The shorts thesis is the trials are too small, bad methodology. But, on the other hand, their is a signal of efficacy now along three lines of cancer.

rGBM shows an efficacy signal in overall survival and how the tumor progresses along spider plots and along waterfall distribution plotting greatest reduction in tumor size as contrasted to standard of care....Avastin.

Ovarian cancer shows two signals with VB-111 in concert with platinum... one survival--although the trial is very small and the low-dose treatment arm only had 4 patients. Then again the biomarker response of CA-125 seems pretty consistent in terms of reduction. Thyroid shows again response.

Thyroid shows response in PFS and possibly overall survival ect... with VB-111 by itself.

The trials by definition are flawed, but only in the sense of a tiny micro cap trying to achieve an efficacy signal. Three distinct cancers, in different combinations... with avastin, with chemo, and by itself ...all showing an efficacy signal.

The other thing that caught my eye in the animal--preclinical evidence of tumor shrinkage and stabilization of tumor growth in different tumor types... lung, GBM and others.

While every biotech and their nephews all work in the same area.... checkpoint inhibitors and in CAR-T, crowding up the space, VBLT is working in a completely different manner. No, VB-111 is not curing cancer, but it may be extending life. The other piece of evidence thats encouraging is the immune infiltrates shown at ASCO in ovarian tumor patients. This fits in with the immune mechanism of action and the feverish response that the biotech shorts scoffed at.