Most of the sites listed are not academic centers, that's just a fact. I have worked at 2 of the sites over the past 6 years and neither of them used intraoperative MRI.

Actually not true. Most did not have state of the art resection with intraop MRI

It is unethical. I can tell you that as a doctor and one who is involved in research, it would be highly irregular to buy stock in a company testing a drug I developed. It would be regarded with severe disdain by the scientific community and would have to be disclosed during every talk on the matter. Professionally it's a big no no.

86% of 331 = 285 patients received dcvax
285-221 = 64 placebo patients crossed over to dcvax

14% of 331 = 46 placebo patients progressed but didn't cross.

This means 64+46 =110 placebo patients evented.

Is this accurate?

Thanks

I agree with your point but if these 20% have not yet evented than the trial will end too early to capture their events. There is no end point that accounts for these noneventers...

Here's a thought experiment. Say the only benefit of the vaccine is a near cure in those 25% long tail patients and that there is no PFS benefit for the remaining 75% of patients. 2 questions:

1) with the current study design would we fail to meet primary endpoint?

2) is this a theoretically possible scenario?

Thanks!

So with the defined end points is it safe to assume that the full benefit of the vaccine may not be captured in the trial (long tail)?

Flip what if the mesenchymals are not eventing at all and therefore we are not reaching the 248 events? assume that all 110 placebo plus all the non-mesenchymal treatment arm patients evented at the same expected PFS (no benefit) and we are now waiting for the trickle? In that case the trial would fail no? Is this mathematically possible assuming 30% mesenchymal?

Very strange indeed. Definitely more happening behind the scenes than what we can even imagine.

hows your short at 0.61 doing?

LOL

Unless the deal in the work is a crazy dilution the likes of which we have never seen. I hope not but the truth is they are desperate for money and who gives money to desperate companies...

Question. Why would the put forth this latest PR 1 day after the PR of delisting? The whole sequence of events is very puzzling to me. Any theories?

Radical prostatectomy is the most aggressive way to go. Impotence and incontinence are a small price to pay to get a Gleason 9 tumor out of your body.

My 2 cents

Hopefully sooner rather later ready

Clinical gov was just updated recently to Nov. so that means the primary end point has not been reached yet.

She isn't the PI

No evidence of elevated relative blood volume, hence not progression.

Actually, since PFS is blinded and not easily obtained in a blinded trial whereas OS is pretty obvious, I would interpret her comments to mean that she knows patients are living longer and she assumes it's because of the crossover. Whereas she has no idea what is occurring with PFS.

2 possibilities:

Optimistic: combo trials have not started because Linda is waiting for confirmation of a successful L trial to use as leverage with big pharma.

Pessimistic: nwbo knows that L has failed and they are waiting to announce the results until combo trials are announced to 'pump' the stock price.

I have 250 contracts. My dad has 300.

:(

Incorrect

I didn't say it looks like pseudo progression so let's wait and see.

I said, it isn't a mass and therefore does not meet the criteria for progression, let's wait and see.

The quote I gave you very specifically says the word mass. If the radiologist cannot call it recurrent mass unequivocally it also goes on to state that the decision may be deferred to the next MRI. Never did I say I can distinguish pseudo from true progression. I said that the criteria allow to defer that decision.

It is you who are claiming that any 'thing' that is New, T2 bright and or enhancing equals progression.

You are wrong.

I have first hand experience with serving as an 'objective' radiologist on these types of trials.

You are over thinking and misunderstanding how things work because you are not a radiologist. Words like 'mass' mean something very specific to radiologists.

No it's says "mass". Therefor if it is not a mass (as your images show) but is merely amorphous signal abnormality than it cannot be called progression.

You are wrong. I am now sitting in front of the latest version of the protocol. I will quite a line for you(well not you since you aren't invested and have no interest, ehm):

"If progression is not defined by these studies, treatment may proceed and determinations made at the next scheduled MRI"

So you are wrong. Equivocal means continue until next MRI. Drop it already.

All reads are subjective, especially where it pertains to GBM response. Blinded or not blinded, the reads are subjective. Equivocal is equivocal.

You are wrong (still).

1) these images do not show "clearly defined margins" which are necessary as you just pointed out.
2) the 2 rows aren't even through the same part of the brain! They nights as well be from different patients.

These images represent equivocal findings based on all criteria you cite and would be scored as such.

Yes

Yes

It's pretty simple actually. Avastin inhibits angiogenesis. Do you know what contrast enhances MRI relies on? Yup leakage of contrast through angiogenic tumor vessels. So it doesn't mean tumor isn't there it just means that the MRI can't show it.

He doesn't get it. He thinks because it's a clinical trial it is somehow possible for these radiologist to do the impossible by calling something that is equivocal unequivocal.

"Tumor or inflammation or whatever else is worse"

That does not sound like unequivocal to me.

You just don't get it do you? The radiologists reading the trial scans are the same as any other radiologist. Equivocal means equivocal. Patients will be followed and not called progression. Period.

No it doesn't show a mass.

All the criteria you cite mention terms such as "mass", "tumor" and "unequivocal". Nothing about those images looks like any of those words. Radiology is not black and white which is why you need to look at thousands of cases before you 'get it'.

You can start by looking for MRI images on google and comparing them this example you love.

And by the way, the criteria are as specific as they can be in such a nonspecific scenario.

It's a big hand waving and judgement and experience will make the difference.

By the way, I happen to serve on CROs for drug companies at my institution so I do have some idea about this...

You're wrong

I'm a radiologist.

I can tell you that he is wrong, FACT

When did NWBO sell shares PUBLICLY?

100% agree

You can't blind death

But once they hit the primary everyone will be on dcvax. So what would stop them from unblinding? No more placebo...