Guesstimate of 2nd-Line NSCLC MOS from KM curves:

Placebo + 1mg/ml) Combined: 7-9 months

3 mg/ml at least 13 months (assumed - based on previous info)

You explained stat sig well but something needs to be added. The p < 0.05 is really arbitrarily set number, it is 5% or second standard deviation. What that means is that if a drug is approved with p=0.04999 the chance is still about 5% that the drugs really doesn't work and the result of that particular phase 3 was a statistical fluke. We could have set the standard for approval to be first standard deviation, or the third one, or any number in between. So saying that p=0.04999 is stat sig and p=0.05001 is not and sticking strictly to that as a condition for a drug approval is almost ridiculous.

1) The September trial did not have the problem. As explained the more extreme the results are the less it can be obtained by chance in a clinical trial. The 13.2 MOS was double the SOC MOS and extremely high compared to the Historical SOC MOSes. So or it must have been Bavi or there is an error in the data analysis or there is some cheating involved, but by chance you don't double MOS.

The problem is WITHOUT ANY DOUBT the ECOG 2 patients. I cannot answer why they allowed them in the clinical trial. However it is not important because the trial was not seeking significance as FTM pointed out already and my post was a aimed at explaining why PPHM best didn't provide p-values WITHOUT providing also the full detail. The full detail is for a scientific conference, probably under embargo(ASCO?).

And the following is incorrect, that claim hasn't been made, the words sex, age don't even appear in my complete post. I am glad you kind of bring it back to "overall tone" in your 3rd post.

So the answer is : NO, the 3mg MOS can't get better, at the best the control arm could get some worse.

Well there must be something wrong with your hearing because for starter my posts provide all reasoning and basic data available.

Why do so many and especially Biovalue board guys harp on stat stig for phase II trials.,are most phase II trials designed to be stat sig? I thought most were designed to show safety and and enough activity to be approved to go to ph III.

Has there been anything that has shown to be effective for pancreatic that isn't some form of chemo agent? My guess is if Bavi shows good lung data and partners then we will see Bavi down the road for pancreatic based on subsets or in combination with Gem and Abraxane

The patient assignment to the arms have a huge impact on the results as was demonstrated a few posts ago. Would the patients FIRST have been grouped in ECOG groups and each arm would receive an equal number of 0,1 and 2 patients then the external factor would have been eliminated. Hard to do because it would imply that you know the ECOG of all patients that are going to show up during the enrollment period in advance, which isn't the case. Assigning them on the fly with a toggling technique is possible but would open the clinical trial to a certain degree of 'fixing' because in a non-blinded trial if two patients of a same ECOG group show up one could systematically assign the less sick one to the Bavi arm and the other to the control arm. To make this possible an provision that isn't available today for clinical trial would be needed.

So BAVI arm had almost thrice the #'s with a PS = 2 !!!

With the Freedom of Information Act, you would think there would be a site for info on the drugs submitted to the FDA for breakthrough just as they have the trial site

Wake up and follow the libretto. There are no new patients enrolling in the 2nd line test. Enrollment is closed.

It's median overall survival, not mean. Once half of the patients die, the median won't change. However, half weren't dead when MOS was announced, so it should be higher.

MOS is when half the patients die in Bavituximab arm. How patients are enrolled? Figure it out!

Bavituximab arm MOS in both trials to be PR'd

So the real question is not whether there will be a Ph III trial, but how many patients will be required in that trial (e.g. 300 – 400 patients) and whether the FDA will accept an “interim look” at some smaller subset of those patients (e.g. 100 – 150 patients) as a basis for cutting short the trial and granting immediate approval 1/3 of the way through the trial.

PPHM already has a conjugated TNT product...

Peter Verdult - Morgan Stanley & Co. International Plc

Yes, Pete Verdult from Morgan Stanley, just two high level questions Pascal, just firstly on the CNS division. You’ve made some comments about how you’re thinking about respiratory with the ongoing loss of Seroquel, how should we be thinking about this? Just a dismantling of the infrastructure as CNS declines, relying on your virtual R&D business model, or BD in partnerships to compliment the infrastructure you’ve got? And then just on the pipeline, I mean you are fresh pair of eyes at Astra. I’m sure you can tell us that you’re excited by the whole pipeline, but it is just the couple of assets that really excite you in the early stage, that I’ll be interested to hear what they are?

So, this probably would be some of the most intriguing products. Selumetinib, I have my doubts, I must say, but we have good data that are shaping up, ...

Those who are new to PPHM are only hearing about Cotara in relation to GMB,but Cotara can be used on all solid tumors.

The Stimuvax (L-BLP25) story. This is interesting.

Would like to hear if anyone disagrees or finds other key differences......

Cell Therapeutics (CTIC -0.7%) says the Gynecologic Oncology Group has informed it that an independent Data Safety Monitoring Board has recommended the continuation of Phase 3 clinical trials of Opaxiotm, a therapy for ovarian cancer, with no changes following a planned interim survival analysis

So does a company in a clinical trial deny cross-over treatment until they know the trial has been/will be considered a success? Seems like it would be taking a big chance otherwise.

The results from the Threshold Pharmaceuticals TH-302 pancreatic phase 2 trial are very interesting. The MOS was very good a 9.2 months but the results for the HR and associated P value were very bad.

What I find real interesting is that even with the bad HR and P value results, the FDA granted a SPA for their upcoming phase 3 trial.

Any rationale why all the censored patients are at the end of the plot as compared to the BAVI trial where they were spread throughout?

Exwannabe...if u don't mind...what did you wannabe?

Well, can you suggest any better method to gauge whether Bavi (PPHM) is making progress or not?

I always thought MOS was reached when there is no 50% of your patients alive. Ok there may be some extra complications if patients were censored or if 50% of the currently enrolled patients died while the trail is still enrolling etc but I am pretty sure the conclusion is not reached by trowing arrows to a dart board.

I would think the NCI dictionary of cancer terms would set a pretty clear precedent:

MOS is a material event, it should be announced.

As you will see in this movie they claim they can change EVERYTHING LAST MINUTE without any important overhead. That means that the advantages of their On Demand Packaging and Labeling may well have worked AGAINST the security of the PPHM (and others) clinical trials management.

Next... what makes the trial statistically significant? To keep it simple, it becomes more statistically significant the larger the (n) ... patients involved in the trial? I assume that is correct

Now... if what some believe that if 2nd line NSCLC shows historic "mos" and "safety" ... but lacks in the statistical significance due to the combination of the 1mg/placebo arms... and the # of (n) 3mg Bavi arm not large enough....

Do you have any money at all invested in PPHM?

af did voice his opinion and he said it didn't have a hells chance of being significant.

I bet in places like China and the UAE they would cut an arm off at least for insider shennanigans.

I think people should have gone to jail on DNDN, SPPI, HEB and many others. AF was under SEC investigation on HEB wonder if they will ever press charges for that? The head of thestreet.com was just in trouble for fraud... PG

NO Sherlock, that is not true - the antibody data is what helps make this deterination. Then he muddles things further by implying the inability to distinguish the 1 and 3 mg doses from antibody data, by connecting this to the placebo / drug data.