In thinking about Overall Survival I believe that it's important to look beyond median survival. In our case we do have improvement in the median, but what if we didn't, what if it was identical, but it separated when 3/4's had passed on but the tail flattened out and was well above the SOC. That too should be an approvable product.
I wonder how many products over the last 20 or more years had trials ended because of futility based on PFS because they knew nothing of pseudoprogression, but that's what was occurring. I think we must credit Dr. Liau and associates and L.P. for making the determination that PFS wasn't a proper goal for success because of pseudoprogression. I have a feeling that many companies would have abandoned this vaccine many years ago.
On the subject of bringing in a more experienced CEO. While I believe that Fireman is right, share price would increase dramatically based on increased credibility. Frankly I believe that new CEO might have found that there was nothing left to do. I think the CEO would find the BLA's etc. were complete, or near complete, the FlaskWorks unit was certified or close to being so, documents were developed and ready for signature to manufacture and distribute DCVax-L upon its approval, and perhaps a partnership or buyout offer had been developed and just awaited certain events to occur before it could be announced. I don't know that this is the case, but I don't know that it isn't. If it is, that new CEO would have the easiest job of all time, and would make a fortune based on L.P.'s work. As to the stock holders, with or without that new CEO, when all these things are done and DCVax-L has been approved by all regulators, I believe the share price ought to be about the same whether we had a new CEO or not.
If I'm right, much of what's happening during the quiet period will be discussed either at the ASCO Experts Theater or at the Annual Meeting. At that time I believe it would be much fairer to judge what the company has done in the last 20 or so months while under the cover of a quiet period. Of course I may not be right, or perhaps the company won't want to reveal their entire hand at this time, we'll see in roughly a month.
Monday's IMHO are considered the best day to announce positive news as they give brokers the most time to work their clients while the news is still considered fresh. I believe that in the next two weeks, prior to the ASCO presentation, offer the opportunity for two things from the company, one being the notice and proxy for the Annual Meeting, the other being the TLD statement with information about the Journal. I can't say it will happen on Monday's, but it could. Next Friday, after the close, is probably the best day for bad news because next Monday's a holiday. I really don't believe the company has bad news to announce, but they may feel that what they're proposing in the proxy will be taken that way. My point is that I believe that news will be coming in the next two weeks, I'm hoping it's news that we see on Monday or Tuesday.
Gary
