Any predictions? My guess is a continue which really will be a non-event for the stock price however, a "continue" I would think would be fairly easy for the DMC to determine and I think news would have come by now.
A stoppage for futility I would guess would take some time as the company has millions invested (as well as shareholders) in the trial and they would want to be completely sure before stopping it for this reason. I would assume a stoppage for futility would also completely negate any compassionate use approval by the FDA as well as anyone interested who has GBM.
A stoppage for efficacy I would assume would take time as well, again as the DMC would want to be completely positive of the trial. This would support compassionate use I think as FDA approval could be up to 14 months out and they wouldn't want to keep this from the public who could benefit from it while going through the approval process.
It's also been 7 months since the start of the direct trial. Powers has stated that it's fairly "rapid" if they respond and it's open trial so results will be released as they are known. No direct results have been released by the company.
What I find odd is the last SEC filling with the MFG about ramping up production, compassionate use for both Direct and -L, the statement of supplying DC Direct for over a year (which I found odd since the trial is only 7 months out) and the compassionate use of DC-Vac L in the US. It's my understanding that the FDA has to
approve compassionate use. What I did like about the agreement was the 30 month lock-up period. I don't know how enforceable it is, but it's nice to know Power's isn't using this as a "back-door" to sell shares and gain her money back since she has a vested interest in the MFG as well.
From a patient perspective of those in the trials giving them hope (or false hope as the case may be) and from an investment perspective, lets hope this isn't all smoke and mirrors.
From the press release on December 10: "Due to the work involved in auditing and preparing the data, and conducting the review, it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now."
"Due to the work involved in auditing and preparing the data, and conducting the review, it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now."