This phase I trial was as small as they get, conducted on just 9 patients. There was no control group. 3 of the 9 patients experienced a reduction. 2 patients experienced tumor stabilisation, and 4 patients experienced and increase in the size of their tumor.
This was a small safety trial. The efficacy results are not statistically signifiant. I.e., the tumor stablisation/reduction over the trial period in those 5 patients might have happened even without treatment. We just don't know. All the trial can claim regarding efficacy is that there are "signs of activity against metastatic melanoma."
The safety and tolerability data should be enough to convince the FDA to allow a phase II under an IND. But even here, there a no guarantees. One of the issues the FDA is sure to look at re safety is the small sample size of the phase I.
My guess is that VLA will look to take advantage of this explosion in the share price and conduct a $15-20mill raising ASAP. A good guide to the price next raising will be a 50% discount to where VLA is by the end of this week.
With a fully diluted market cap of $55mill+ (at 12c), with virtually no cash, and with a large raising on the horizon, it is hard to see where any rational short term upside is going to come from. Still might be good for a quick trade, but this thing could easily crash back to the 5-7c range if clear heads prevail.
VLA Price at posting:
$1.15 Sentiment: ST Sell Disclosure: Not Held
