Flipper44, I cannot see a downside to informing the public of the 233rd event occurring. And, I do not think they can state something different to new or NDA covered investors than they informed public shareholders without then communicating the same to the public shareholders. But, they did use the term "minimum" and I don't think they specifically committed to informing us when the 233rd event occurred but that they would keep us posted on progress. If all is true, then either they:
- are continuing the study blinded because the 233rd event has not occurred (not likely but wouldn't that be wonderful for all)
- are continuing the study blinded beyond the 233rd event to reach another statistical endpt, since they used the word "minimum" when talking about the 233rd event (possible but if so I don't believe they can give more info to some investors that has not been publicly shared)
- have engaged immediately in a regulatory process with FDA and will not communicate until it is completed as they have stated before regarding regulatory processes
Remember, companies try not to be put in positions where they either have to lie or reveal info they do not want to reveal, which is why quiet periods are self-applied. When in that situation they have to say "no comment" and then the interpretations are wide open. So, they keep their people at the office and the phones channeled to IR.
I think that if the 233rd event has not been reached they would communicate that, it is a very bullish sign but one that makes sense to divulge, and, not a reason to cancel presentations. They would communicate this unless they are working with FDA in the approval pathway.
I think that if they are pursuing data beyond the 233rd event that they would have communicated the 233rd event occurred and then stated again that the data examination and review period will continue for a bit longer, which would all be true, and, data lock would occur once all is ok'd. This however could preclude their presence at conferences as once the 233rd event has occurred everyone knows that they know the blinded and blended results if nothing more. But, that can be telling. But, I think they would communicate that because that would be bullish given the timing of the study and it would explain the quiet period, unless they are in FDA discussions about an imminent regulatory pathway.
I think that if FDA discussed filing with them (whether the 233rd event occurred or not, but, assuming it did) that they would commence immediately and we would not hear until a final approval ruling was taken by FDA. Their reasoning would be that they were into a regulatory process and decided not to talk about it. Given the market need for GBM therapeutic alternatives and the absolute lack of safety issues with DCVax-L, this is the only logical thought. I am going to go far out on a limb here and state they are hoping for a positive FDA response by EOY and want to hold the ASM until they know that is their news. Otherwise they have a very convoluted situation to explain and I would love to hear that live. But, then again, I would prefer to hear a positive FDA decision, whether live or not. Bottom line for me, sorry for so many words, is that I see no reason to not communicate whether the 233rd event has been reached unless they are into the regulatory approval pathway with FDA and we know they do not discuss such things.
