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Excellent research!
If you read up on what happened around 2008, you may be able to figure out whether or not my first sentence was sarcasm.
You do realize that the big banks are the enemies of FnF, right? They want the mortgage business for themselves, they caused the housing crisis and then passed the buck to FnF, got off scott-free and are now even bigger and more powerful than they were before.
Where did you get the impression there was a placebo in that study? It was an open label trial of carb + bavi vs. carb alone. Clinicaltrials.gov does not list a placebo as part of the comparator arm. In an open label trial there wouldn't be much need for one.
Do you see this as consistent with, more pessimistic than, or more optimistic than your model's estimate of $4B at peak throughput?
Just index funds rebalancing. Check any other bio that was recently added to the nasdaq bio index and you will see the same large after hours or end of day trades.
I tend to defer to people with more experience in trading around an approval than I have, but my opinion is that approval is priced in. Given how high the probability is, the market would have to be really blind to not have that factored in. The more interesting issue, imho, concerns what assumptions about the details of the approval/labelling have been priced in.
Another round of small 10b5-1 sales by Mellett and Luly reported yesterday. Nothing significant as their holdings are still quite large, but mildly interesting that Mellett sold on Friday but didn't report until close of business Tuesday with Luly selling on Monday.
Remember when one of the "reasons" for the reverse split was to decrease the volatility?
Recent preclinical peer review while we wait for more substantive developments:
http://www.ncbi.nlm.nih.gov/pubmed/25229164
CP, that is a bad translation on your part. The trial is Pending, it is not on hold. A clinical trial "on hold" is a bad thing.
Do you really think that the BOD would give an interesting answer to questions about their legitimacy? Seriously? Something like "gee, we hadn't noticed that we are all tied together and don't have any pharma credentials, but now that you mention it we'll go ahead and add some independent industry directors."
Nope. The answer would be "We hear what you are saying and understand your concern but we feel that the BOD as it is now is best suited to carry the company forward. When the time is right to add more directors, for instance as part of a partnering or other collaboration, we won't hesitate to do so. Thank you."
200,000+ share transaction at the ask.
Something is clearly going on.
You may not be interested in my opinion, but I have been holding since the sub .20 range. I don't post much on here (the way this forum is moderated doesn't interest me very much), but I used to post more a while back.
In my opinion this won't have any significant impact on Punit's day-to-day management of ONCS (being on another board doesn't really take much time). Also in my opinion, Punit as CEO has a cloud over him (he lacks the experience and credentials of typical legitimate biotech ceos, and his position in the company is presumably due to his father whose past business dealings, again in my opinion, are not totally savory). Given this, associating oneself with the MJ sector won't help.
I know nothing, at the moment, about the particular company he will be directing. Maybe it is one of the lone bright spots in the sector, who knows.
Wow! Can't imagine a better move to give your OTC biotech company genuine cred than to join a bod in the hyped-out, pump & dump, scam-ridden sector of medical mj stocks. Oh wait, I was wrong. Pretty much any other move would have been a better one.
Not certain that it *has* to be, but I doubt there is much precedent for approving a new drug with a new MOA without a clean comparator arm.
As was pointed out the 3mg arm was not tainted, but the placebo arm was. So instead of having a clean placebo arm to compare against the 3mg arm, they had to pool the placebo arm and 1mg arm data to use as a comparator. Against that pooled data, the benefit of the 3mg arm did not reach stat sig. So no AA.
For part of the answer, just compare the BODs of the two companies.
Just a guess:
http://en.wikipedia.org/wiki/Peregrine_Systems
Perhaps Bayer is using HP's Peregrine IT management system
That is an interesting one.
My bad - Thought you were talking about a trial for an experimental front-line alternative to chemo.
Recruitment can't be dependent on funneling patients from a front-line trial of a different experimental drug as they wouldn't meet the inclusion criteria.
Inclusion criteria require front-line platinum based chemo:
No record of it in clinicaltrials.gov
Good to hear from you.
Personally, I doubt anyone would license vgx-3100 and let INO continue to develop 3112 on their own. Who wants to put money into something only to have an augmented version of it as a competitor.
Uhm, no. It simply shows that for whatever reason MaPP was better positioned to experiment on these aid workers. I have no idea whether pphm will ever market an effective anti-viral. I certainly wouldn't invest on the belief that they will, though.
It is impossible. It has already been released that it is a three mouse mab made by Mapp that had limited success in monkey trials.
That isn't really relevant to PPHM's situation. PPHM is not trying to conduct three look-ins and then combine all the data together. The hope is that *one* of the looks will be sufficient to rule out mere luck all by itself.
To keep it simple, if you tested a placebo+soc vs soc alone and only required a p-value of .05 for any one of three looks, then there is roughly a 15% chance (3 x .05) that one of those look-ins will show the placebo to be stat sig efficacious. Needless to say, the FDA won't approve a new drug if you can only show an 85% chance that it works.
The more looks you want to take, the lower the p-values have to be to achieve stat sig (though as ex... said, there is flexibility in how one allocates the alpha and pphm need not disclose to us how they set it up).
I will also be curious to hear more from E'man when he gets a chance, but a couple things that it might be useful to know about p2 --> p3 trials.
A p2 trial is not really about achieving statistically significant effiacy data. Generally, p2 studies are smaller (to save money) and stat sig is largely about having a large enough sample size to rule out luck. What you are really looking for in a p2 is a sign that there is efficacy (of a sort that would be worth developing a new drug for) and safety.
The FDA does not require that a p2 be statistically significant in order to run a p3. While I haven't done massive reviews of study numbers, I would bet that most p2 studies that go to p3 did not have statistically significant results.
For those who don't know, when a study is reported with a p-value of <.025 that is saying that there is less than a 2.5% chance that vgx-3100 is a placebo and its apparent efficacy was the result of luck alone. If the p-value had come in at .06 (6% chance results were due to luck) it would not have met the standard for statistical significance but it would still be a pretty safe bet that the results would not mere chance. In a p3, the FDA requires that you meet the stat sig threshold in order to approve the drug, but you are way more likely to meet the standard when you work with a larger trial size.
Keeping that in mind, I have absolutely no doubt that INO is takign vgx-3100 to phase 3. There has been some speculation that in conversations with the FDA they will be permitted to add an adjuvant (IL-12 or IL-33) in the phase 3 which should further improve the results. I don't know for sure whether they will end up doing that, and I have no idea whether they will partner for the phase 3 or not, or whether they end up with even better data in a predetermined subset and so narrow the inclusion criteria for p3, but they will be going to p3 and it looks like it won't have to be a huge trial in order to be reasonably sure of hitting stat sig.
Wow, they couldn't even let us enjoy good news for one night.
Why now given that they still had over $60,000,000 from the feb registration (which is now rolled into and part of todays 173...)
This was pretty much expected. It is precisely because it is well documented that the body can clear it naturally that INO thought it would be a good candidate for getting clinical benefit out of increased T-cells. The thought was that if the body can do it naturally, then it must be the t-cells doing it. Increasing the t-cells via therapeutic vaccine should then increase the regression.
There are various estimates for percentage of natural regression from various study. INO stated that they assumed 25% regression, some studies have had as much as 40%. Given the small size of the control group I wouldn't read much into the specific percentage achieved. It could easily have lower or higher if a patient or two had gone the other way.
Just filed an 8k with the SEC for it, too.
I don't know, that's why I was just echoing the PR's numbers but putting the percentage in a different light. Maybe the neoplasia are (part of) the bodies response to the virus and they can persist even after the virus has cleared. Maybe all of those will have complete regression. In terms of how to think about the rest of INO's deep pipeline, though, I like the high percentage of viral clearance among the responders.
The 43 out of 53 wasn't complete regression. It was the number who cleared the virus out of those who showed regression. The secondary endpoint was viral clearance *and* regression to CIN 1 or no disease and was reported as 43 out of the 107 in the experimental group. Since 53 of that group regressed, a little math gave me the number of regressed who also hit the secondary endpoint. All the numbers were from the PR.
Thanks again for point me in INO's direction back when it was well under $1. It has been a fun ride so far, and I think it is really just beginning.
Agreed 43 out of the 53 who regressed also cleared the virus entirely.
He's a turd. I would like to see him explain his "missing patients" barb. Expected enrollment (according to clinicaltrials.gov) was 148 with enrollment going 3:1 to the experimental:control. Data reports 107 in experimental and 36 (35 for secondary endpoint). With a p value of .025, I don't see the 5 patients lost to follow up (and that is assuming the trial did enroll the full 148) meaning much at all.
Congrats Longs!
Statistically significant clinical efficacy in a phase II with no real AEs!
Results would need to be much better than P2 to stop early. See my earlier post about how conducting multiple looks requires a higher threshold that p<.05 for statistical significance.
Personally, I doubt that it would be stopped so soon. It is important to keep in mind that the more times that a data monitoring committee plans to look at the data to make stop/keep going decision, the higher the target p-value has to be to count as a success.
As an example, suppose that you are testing avastin against avastin (in other words, there is no difference between the control and experimental group). If your target is a p<.05 then every time you look at the data and run the numbers there is a 1 in 20 chance of finding that the experimental group is stat sig better than the control. So suppose you plan to look at the data 20 times while it is accruing, then you are virtually guaranteed to "discover" that Avasting is better than itself and that this superiority meets the threshold for stat sig.
This is why when conducting multiple interim looks, it is essential to use a more stringent threshold than .05 for statistical significance.
The company has not released a specific time - so anything you hear is most likely speculation unless someone is leaking insider material info. The company has advised late July (though nothing commits them to that), and Kim has previously said that they would like to release at a conference. Wed. is a logical date given that the CMO is giving a talk at an Inovio sponsored event. Maybe a release of topline results in a morning PR and then some additional color in the talk?
Anybody who really knows probably isn't talking and anyone who is talking probably doesn't know.