The whole regulatory process for developing drugs is loaded with delays. I've seen trials take 6 months or more just getting underway after the IND was approved. The IRB and lead clinician couldn't schedule it any sooner.
It disturbs me how much trials cost, especially when they're for diseases that are deadly and have been proven safe in Phase 1. I believe it's very different if you want to be certain a new headache, arthritis, etc medicine is safe and effective, be very safe in that trial, but when you are testing a drug for people with deadly diseases, like GBM, trials should not take over a decade and require the sort of proof that this one has.
I realize the company made the choice to go for survival, probably because only a certain number of patients had a big benefit, while other may have had none at all, and an earlier look wouldn't have shown the advantage. A big part of the problem is the way the FDA wants to do everything with statistical analysis, rather than opening their eyes to what is an obvious advantage of certain new drugs. I've seen many drugs not approved that clearly had some advantage, but didn't meet their statistics. The problem is, companies don't have the funds to redo trials based on what they've learned, to achieve the greater advantage required, even though they believe in a differently designed trial that they could do it.
Most tiny biotechs simply don't have sufficient funds to run a series of trials to get a drug approved, if they should get a BP partner, additional trials might be run. The problem is, the BP wants the drug for a tiny fraction of what it should be worth, and companies won't sell many of the time. LP is doing this the right way, show what the drug can do before considering a partnership, or buyout. I just hope the data is so strong it leaves no doubt, and that DCVax-Direct can be in trials shortly, either financed by a partnership, or limited dilution because of a substantially higher stock price.
Gary
