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The company is claiming the patients were platinum “refractory” rather than platinum “resistant” and claiming that the refractory patients have a much shorter expected survival.
They do have a SPA. It may depend on how strong the results are.
The initial trial demonstrated safety of a single treatment by intratumoral injection. When this produced only mediocre results, the company went back to the clinic.
Later trials were needed to demonstrate safety of intravenous administration, longer term usage, and usage in combination with radiation and various chemo drugs. The investigators and the regulatory agencies were very cautious on this product initially - understandable since it’s a high dose live infectious agent being administered to immune compromised patients.
It was also necessary to work on manufacturing issues as a lot more product was needed for larger trials using intravenous administration than could be provided using the initial laboratory techniques.
In this light, the 8 years it took is understandable but I’ll grant that the CEO should have been more open about those early challenges.
The poster was produced by independent investigators so I doubt it was part of a stock fraud. I believe the point was that time to progression could be used as a proxy for overall survival and this is how the registration trial is designed – with an initial look at time to progression (overall survival is the primary end point, not time to progression) in the first 80 patients in order to power the trial.
"One thing to look out for is the private placement at $.50 having to be worked off before the price can really rise, but I guess that kind of downside I'm willing to live with."
That PP was very small and Sprott doesn't tend to play those types of games so thats not the concern. There are however 30 million in the money warrants due Feb 20. Many of those holders won't want to cough up the money to exercise and some will short against the warrants to lock in a gain. I'd rather own them now and wait it out then try to be cute and determine exactly when the fast buck traders will decide to pile in.