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Did they just increase the common shares?
Re: Prana1 Post# 646
1. To be clear Prana1, VBLT "completed enrollment" for Ph3 rGBM. You mention several times that the "trial was completed", and so I feel that it worth clarifying.
( worth clarifying!!) ok.
Yes the trial was completed and the trial completed enrollment are two different things. But people following this thread probably understood that the results are not out. But thanks.
2. I agree, the fact that so many doctors believe in (and recommend) VB111 is amazing and should not be overlooked.
(Yes)
3. VBLT did not really change the trial structure, they changed the analysis protocol. Maybe a subtle difference, but it is not like they changed dosing, scheduling, enrollment, etc. - things that are structural elements of the GLOBE trial. Instead, they changed the requirements for when interim and final analyses are triggered. Take a look at this board starting around Post #545 (gr8db8's comments) to track discussion about this point.
( a change in analysis can mean a heaven and hell difference when applied in the right context.
So sorry sir. Subtle or not. It is a change and will be interpreted as such. Maybe they changed it to power the study better after consultation, but we will see )
4. A bit of your confusion may stem from being newer to this investment? Take a look at some of the press releases on VBL's IR website to get a better historical perspective.
( newer to this investment-- hmm. Let's see. --- thats a relative term.
Newer but not naive would be proper answer, my older friend)
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What gives me the reassurance is that the principal investigator is in the USA.
2) the trial was completed a solid 5 months ahead of schedule. That's a bit impressive- that means it must have been a favorite among the various other investigators handling the trial at various centers.
What I mean by that is that for a particular cancer these guys have quite a few options to plug pts in different trials but they seem to have sent them down this trial. That's a bit of confidence on the doctors part. That's reassuring to me.
3) as soon as they announced that the trial was complete they also announce that they made some changes to the trial structure.
(Under normal circumstances that's a big red hot flag for me and I yank out my investment)
But I haven't had the time to assess what they changed.
That's my work for this weekend.
( if anyone has seen the changes or has comments about them would love to hear about their DD)
Always hoping for the best for pts.
It's time for GBM to be shut out.
Let see.
No no.
All I am trying to say is trying to reply to the original comment about - pts dropping out after suggestion from their personal doctors.
I am guessing that it did not happen on a large scale as otherwise the CRB
institutional board and DSMB - would have red flagged it.
People drop in and out of trials for a lot of reasons. But if there is a large dropout it sends the wrong signals about the selection process and how rigorously they screened the trial pts prior to enrolling.
Take a hypothetical example of a trial trying to enroll 500 pts.
If at the first go they enrolled 500 pts but as it was an open labeled trial 250 of the them receiving the avastin dropped out and of the remaining 250
In the VB 111 + avastin about 125 dropped out as they had no fever. We are left with 125.
So now they recruit again till the process goes on and on and on till all we are left is 500 of the VB 111 + avastin arm and all of them who had fever!!!
Well how is the FDA gonna like this trial.
It's an extreme example. But I hope u see what I mean.
Re: Prana1 Post# 639
1. You could not perform this trial, by definition, without it being open label. VB-111 can produce high fever... how can you completely blind any trial with VB-111 for obvious reasons. This is not unusual or atypical for experimental treatments that can produce unexcited toxicity, edema, pyrexia....
( this is not completely true as only a select percentage of the pts developed a fever, -- it's a moot point though as the trial is already done. So no point in discussing about it )
2. Another similarity would be the Duke poliovirus rGBM trials or many of the checkpoint trials in their earlier stages.
3. We know from INSPIRE that some of the Avastin only patients dropped out before receiving Avastin. How many? According to Harrats, the CRO told him that drop outs were not a problem or out of line with which is to be expected. I don't think he, legally, can make such a statement if its not true.
( true again - we know that is true for every trial )
4. People with deadly disease drop in and out of trials constantly. They have no choice for obvious reasons. One patients' husband on the INSPIRE forum has ben on like four immune modulating experimental trials for rGBM(including VB-111) over the past 12 months and is reportedly thinking about joining another.
( true again )
5. It's my understanding the way the trial is calculated is as follows: let's say someone drops out after randomization but before study drug is given... so the computer spits out VB-111/Avastin or Avastin only and, the person is upset, and drops out before Avastin, then he/she would not be calculated, but if a person receives a single dose of Avastin or VB-111 and then drops out due to progression or any other issue, that person's overall survival would still be calculated... so if a person drops out after progression to VB-111 or Avastin, their overall survival data is still inputed into the results, but that would not apply to a person who was randomized into the trial but never got study drug. I actually got this information from an old google patent search on the design of the trial, which interestingly also gave some criteria for early stoppage at the interim with a P < .03.
(That's exactly what I am trying to say - if a pt rolled in the trial and is on vb111 + avastin - or even avastin and then drops out as he has no fever, then the drop outs will increase and
DSMB - won't like it that inadvertently they are picking up responders as manifested by fever.
But that did not happen so I am guessing that's not the case.
6. If anything, the trial is already suggested something else interesting: there is no overt interaction between checkpoint inhibitors and VB-111 since many of these patents have received both... not in tandem but within a month or so of one another. There may be some interesting post-hoc analysis of a distinct cohort of patients who receive a checkpoint inhibitor and VB-111.
( and agree again- it's all over. )
Report TOS
Oh wow. And the SaFety monitoring board (DSMC) let the trial progress inspite of these irregularities.
I know it's not blinded. That's what makes me very cautious of the results - when they arrive.
They can cherry pick the responders.
I think we are venturing onto something else here.
But yes the pt has every right to drop out. But if that's the case then there would never be a study where we can use placebo. Luckily in this study both the arms have the current standard of treatment.
When a pt signs on to get on the trial it is usually binding on them to continue till the end and in most case even if one arm is placebo pts continue it as it's double blind.
Using fever as a surrogate to check if the pt is on VB 111,is not good as pts without fever also had a response, albeit a smaller one.
And lastly if the pts personal physician ( not the pts physician involved with the study ) is making such recommendations then that's bad as the other arm still has the SOC
And the study group will have to answer about the cause of the drop out pts.
Anyway. I am hoping for the best for the pts here and in turn hoping something good comes of my investment.
Let's see. It's still a long year to go.
I think that even if that was the case that vb 111 did better on its own( I don't think so) the GLOBE trial is not looking at that.
It's structured so that one arm is
VB 111 + bevacizumab and the other arm is bevacizumab only.
So it does not matter
And 2) if that pt on inspire forum was told to drop out if he had no fever then that's violation of the study rules , if he was already enrolled in it.
So I thinking something's missing.
I am sorry. But where did you get this info about1) VB -111 being trialled alone
And 2) about the investigators given a choice to choose which pts continue in the trial based on fever?
Thanks.
What is this
What's happening.
Thanks that was helpful.
The only reason I got pulled to the company was one mention of a feverish response to the medication.
And they noted a better response in those who had the febrile reaction.
They think that it's a immune reaction that revs up the immunity to clear the cancer cells.
I think it's something else though.
Anyway will read more and get back to you.
Thanks.
Trying to do my dd. What's adam f's point of view? Can u quickly summarize it. I can't seem to get a coherent explanation
It already has options
Don't think so. Unless there are other bids. But speculation will push it north of 1$
Ahh. And I was wondering who is buying all those.
PPS now stands at 1 $. Unless they have outstanding warrants.
But Pfizer said they will take over certain contractual obligations.
Let the bidding begin.
Fast track for bextriban!!!
Where did u get that information. Can you please post a link.
I tried the Nasdaq link but it brings me to the institutional holders page. Thanks
One simple query. Does a dilution r/o a buyout?
Thanks
That means a buyout is in the works.
Planning to play it both ways.
Fda decision is in August.
Woot woot
Wow. Data out
Dew. Same pattern today. I think someone put a April 40-60 bull call spread of about 500 options.
Any luck looking into it ?
Last year on the 30 th of August. Some one got about 1 k of sept 50 calls and then in the next week or so make about 400-600k.
Something similar happening in the last few weeks lots of calls being traded and this time their conf call is Friday am instead of pm....
Dew. I have something for you to think about.
Have u see the call options volume recently in ptla?
1.20. After hours.hmmm
The funny thing is that the institutional ownership is at 70 %.
Why? What do they know
Dang should have got more!
But there u go. Big guys getting in.
Plenty will be coming.
It will continue to drop.
Not so sure of that though.
European Ad Comm backs Boehringer Ingelheim's anticoagulant reversal agent
http://www.seekingalpha.com/news/2797866
I am.
Long haul is what till the catalysts manifest
Wonder what's the driver.
Yep. Agree