I do not dabble in options for my own reasons, but I have a brief educational query if you or someone else does not mind. That is: how many call options are currently held by Investors (retail, institutional,mutual funds)?
If you tell me, I multiply that number by 100 to figure out how many shares are waiting to be triggered in options, right?
One other quick obvious observation. The presentation will be on a Tuesday during trading hours.
Anybody notice they did not post this news on your yahoo portfolio page (if you have one)? I see this as yet another good sign. (When this stock first made it onto the NASDAQ, Yahoo would only print the chart for the prior couple days. They did this for over 3 months.)
I wonder what that percentage goes up to if you include options and warrants?
By the way, really nice site for this metric.
I believe these studies would modify to unblinded phase 4 trials (aka: post approval trials). Where everyone gets the treatment. Just from a market and FDA standpoint, this makes sense because patients are reluctant to enroll in blinded trials when they know something could extend their lives. Otherwise, this disease is a fast death sentence. The logic continues in that NWBO is expanding their compassionate use.
If you've seen Linda's Presentation live or on a webcast, you'll know she likes to make new announcements at those times. Point and case: Watch the full Roth presentation.
The Primary endpoint is progression free survival.
"The Company has designed and powered the Phase III trial so that it only needs to show one-third as long as the 18.3 months extension of PFS as was seen in the Company's Phase I/II trials to be a successful trial."
This is not an OS primary endpoint, so the dates are much easier to assess for an interim analysis.
We know the enrollment status, and we know in Mid September 2013 Les Goldman told one of our board teammates that they were still on schedule to announce the interim results
in the fourth quarter of this year.
One thing that you will find, which I overlooked (or forgot) somehow (I'm embarrassed to say), is that the interim results for DCVax-L this month will include efficacy analysis:)
It is rare to see phase 3 results come in better than phase 1 results. I think this will happen in this case.
It is important to remember that the phase 1 trial started back in 2004. This is before the standard of care treatment improvement resulted in improving immunotherapy OS and PFS results.
The DCVAX-L phase 3 trial (which began as a phase 2 trial) started in 2007. The standard of care was significantly improved by 2007 (although by itself does not increase OS and PFS by a significant amount). (Note: IMUC's ICT-107 did not start Phase 1 until 2007 when standard of care was greatly improved).
The point is, I am expecting there to be a synergistic impact brought on by the better standard of care in addition to a seamless continuation of "booster shots" in the phase 3 study. (In the original DCVAX-L phase 1 trial, "booster shots" were not continued until after treatment had been stopped for an extenuated period).
Standard of care has continued to steadily improve even more since 2007. Again, by itself, this vast improvement in standard of care for GBM operable tumors has not made a significant difference in OS and PFS, but it has had and should continue to have an ever increasing synergistic impact on OS and PFS when combined with DCVAX-L, and this should only be enhanced further by seamless transition into booster shots.
Consequently, I'll go out on a limb and predict the phase 3 trial will be discontinued this December to provide the control arm immediate access to DCVAX-L instead of the placebo. IMHO
P.S. There are many considerations I'm leaving out, but I think these are further reasons to be optimistic.
You might go back through all the press releases and scientific articles. Once you're done with that, you might go back and look through your own independent research. I found it all very calming. GLTA
Crickets, You keep going with superstition. Let me know how that works out for you.
As they beat it down, I can see why this statement was so prescient. I'm long all the way. See you on the other side....of the dip that is. Hang on.
Auburn Alabama? Just when it seemed like the aristocracy was once again going to prevail, the cagey up-start ran the field on a play I did not even know existed.
You may need to call. My humble search did not turn up the time. Calling works better than emailing with this company in my experience.
Fair enough, and I am not unsympathetic to your warrant situation. Warrants (and OTC shares) can feel like the La brea tar pits. On the up side, maybe they will keep you in the game just long enough to see why you came to the party in the first place.
And here is this from the November 21, 2013 prospectus.
"We have also been working on preparations for the clinical trial in Germany. On July 25, 2012, we announced that manufacturing certification has been received from the German regulatory authorities for the clinical trial in Germany, which is the first step towards implementation of the Phase III trial in Germany. We submitted the application to the German regulatory authority (the Paul Ehrlich Institute, or PEI) for approval of the Phase III trial, which we received on September 16, 2013. As of October 31, 2013, approximately 20 clinical centers are in varying stages of preparations as trial sites in Germany."