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<<Is it possible that we get an update by Friday since Q2 is ending and OS has not been reached>>
I believe that's what they promised regardless of the trigger point (80% most likely) being activated.
EX, Thanks for the answer. Do you know how they randomize it? Let's say we have equal number of stage-3 and stage-4 patients in the trial. Is it randomized in such a way that equal percentage of patients in both groups get active drug or is it randomized regardless of the illness stage boundaries.
Question on open label trials
An open-label trial is a type of clinical trial in which both the doctors and participants know which treatment is being administered, such as the ongoing first line NSCLC Bavi trial.
What I like to know is how do they select patients that will receive a placebo or active drug. Is the process randomized or does the doctor in charge make the call?
Volgoat <<The FDA will need to re-evaluate MOS as the key and start looking at long term Survival percentages>>
You have a valid point, the problem is that would prolong the already lengthy trials. To get a good look at the late separation of KM curve it may take 2 to 3 times as long as it takes to get to 50% point.
Yes, 19 months would be great, especially if the control group is at the historical average of about 11 months for the mix of stage-III and stage-IV that were enrolled. If I remember correctly 84 patients were enrolled - small study and statistical noise can easily skew the results one way or the other.
<<I am not sure we need outstanding results for 1st line>>
The street hates this stock, the proof is in the PPS and low volume. We need it to lift share price and convince the potential partners to offer better terms.
H4B, congratulations, can't argue with success, looks to me you are here for more than just beer. Did you reduce your short position?
Keep_trying, you explained it better than I did. There seems to be an optimum where the treatment produces the best separation between the arms and that is not always necessarily with the healthiest patients. To put it the other way, the optimum benefit point of Bavi treatment or some other treatment in terms of MOS separation has to be found in trials. So, looking at the MOS in first line we may get relatively disappointing results in comparison with 2nd line but one can argue that MOS in this case shouldn't be the only way to evaluate the drug. The late separation in KM curve may be very interesting - the real question would be why some patients respond much better to the same treatment than others.
CP <<15-25% improvement is good for me>>
Not for me, not for the market and not for the partners. This latest price drop has me worried. First line is not a blinded trial, PPHM knows the results, potential partners in negotiations should also know the results. That's a lot of people in the know, it has to leak. I think it actually has leaked already and that's what's been taking the share the price down last few weeks.
Bavi is supposed to be a "miracle" drug, far better than anything else out there in terms of safety and efficacy and to expect 15/25% in first line after 100% in second line would be nothing but a disappointment.
CP <<If we get 15/25% MOS improvement then we have good results>>
Don't agree that 15/25% MOS improvement should be considered good result.
You present compelling case why Bavi should work better in first line having healthier patients etc. Your logical arguments make sense, I am just not sure they are applicable for cancer treatment.
One would expect that any chemo lung cancer treatment should work better as a first line treatment for the same reason - healthier patients. I believe, looking at historical trial data, that case cannot be made. Yes, MOS for the first line is generally longer than for the second one, but separation is not better and in some trials it is actually less. From that fact alone one can draw a conclusion that clinical trial results do not always follow common sense arguments, and that's why we have to run them in the first place. The logical reasoning that works so well in hard science is not always applicable to medical science. All this IMO only, I have no medical knowledge.
Back to your 15/25% MOS improvement - In 2nd line Bavi had 100% improvement that was reduced to 60% because of the Fargo incident. Well, if Bavi only works equally well in 1st line we should get at least 60 to 100%, and if your argument about Bavi working better for healthier patients holds any water we should see 100% plus. Yet, after presenting your case fairly well you settle for a measly 15/25% MOS improvement. Please explain.
<<Options close this week. Had to be dropped below 1.50>>
Not true. Only 1200 call options written for $1.5, 800 for $1.5 puts. I wrote 1400 call options, a mix of $2 and $1.5. Who do you think is gonna drive the price down and for what reason? It's certainly not me, even if I had resources, and I am the major option seller this month.
Seems to me you are just looking for something to blame the selloff on. Look the other way, at the management, that's where the problem is.
You are questioning credentials and business experience of the posters criticizing the management. These questions should be directed toward PPHM management. How many partnership deals has SK successfully negotiated so far? The answer is ZERO. So, according to your logic, anybody is as qualified as he is when it comes to negotiating deals with other entities.
<<SK saying we are in talks over and over again>>
He has no credibility left. In talks since last September, nothing to show for it. That's why the stock price is where it is, no credibility, can't or won't close the deal, endless delays, lack of transparency, bad IR department, useless BOD etc. They are all way overpaid for their performance and should be kicked out.
Look at the handling of Fargo fiasco - total secrecy, not one word of explanation from the management. The mixup is not directly SK's fault but it did happen under his watch and he should explain the circumstances and if they have any proof or indication of sabotage they should come forward.
This management behavior and lack of actions is what is holding the PPS down.
They had plenty of time for negotiations, Garnick and company knew months ago they were getting p3 approval. Look at PD1, already in p3 trial, why can those guys move so quickly. There is no excuse for these delays, it is high time for some heads in management to roll.
The whole market is down big time, biotech is getting hammered. Bernanke opened his mouth yesterday and took the whole world market down. PPHM just dropped with the rest of the sector, may be a buying opportunity.
<<its not IF they will partner, its WHEN and with WHO>>
It's been one month exactly since the phase III approval, and I am sure the management at PPHM knew even earlier that FDA was about to approve the trial. No partner yet, what are they waiting for? They should be recruiting patients now and starting the trial either alone or with a partner as we speak. What's happened with Cotara p3, approved for trial more than 6 months ago and no plans to do it yet - is this what will happen with Bavi too? They are dragging their feet while the competition is already in p3.
<< PD1 is a fraud and a scam>>
Aren't you jumping the gun here, clinical trials will answer that question. Your investment in PPHM is clouding your judgement.
This is, IMO, a bad news for Bavi. They are already running p3 trial and will have to enroll only 264 patients, while PPHM needs 600. That p3 trial will finish at least 1 year before Bavi unless we get accelerated approval. PPHM management is dragging their feet, they should start p3 immediately and could possibly partner later with trial in progress.
You have July calls, I think that's what you posted. If $1.5 June calls expire worthless I will be stuck with more PPHM shares than I should have, so in that case I'll be writing July $1.5 calls on Monday. $2 July calls are barely worth writing at this point, only 5 cents bid. Option premiums have really come down and at some point if the share price goes up some I may consider selling shares and buying October calls.
OPEX shouldn't play a major role this week, actually it shouldn't play any role. Total number of calls and puts for June expiration is just barely above 5K contracts, equivalent to 500K shares. The biggest position is ~3K contracts in $2 calls and those will obviously expire worthless. Max Pain has well defined bottom at $1.5 with ~1.2K call contracts and 800 put contracts. That is hardly enough to influence the closing price on Friday.
Looks like EYEBUY and myself are the major players in PPHM option arena, I believe he is long 1000 call contracts and I am short about 1400 contracts, mix of $2 and $1.5.
<<We should be uber close to major news>>
Avid longs have been singing this song since last December. Yes, we have had news, some good, some not so good - no major influence on the stock price, basically fluctuating between 1.50 and 2 bucks.
What do you consider a "major news" - front line result, partnership, buyout or something else?
Front line is most likely coming this month and unless spectacular it will not qualify as major news. As far as partnership I'll believe it when I see it. Without some sort of accelerated approval coming from FDA we may not see a partner at all, or at least not on favorable terms.
Well, that's the market, some go down, others go up. Look at MNKD - up 6.28%, KERX up 7.57%, VVUS up 3.12% etc.
I am not sure algos did it this time. At 3:01PM someone dumped more than 100K shares dropping the price to 1.48. At 3:45 60K trade dropped it to 1.46 but it recovered back to 1.48 at the close. Volume was low at about 1 mil shares traded, no buyers, and without buyers PPS can't go up.
<<Pre-PR shake out for shares????>>
Doesn't look that way to me, PPHM was holding OK till after 3:00PM when the whole market went down quickly by more than 1%.
<<Losing $1.50 is not good.>>
That depends on your portfolio positions. I wrote a bunch of $2 and $1.5 June covered calls expiring in two trading days. If it closes at 1.5 or a few pennies below on Friday I will not complain too much.
<<maybe you should sell and watch this play out from the side lines>>
No way. Yes, I have some discomfort, particularly with the lack of transparency and mediocre BOD. However, the Bavi potential in terms of risk/reward trumps my level of discomfort at this time.
I do trade part of my position on occasions with some success and have written probably more covered calls on PPHM last few months than anybody else on this board in an attempt to lower my average purchase price in case of PPHM failure to negotiate a partnership and resulting PPS drop. If the stock takes off then the difference in average purchase price of 25 to 50 cents or so will be meaningless.
The way I see it - downside from here of about 75 cents would be absolute worst case scenario. The upside is bigger for an order of magnitude and if we only have 50:50 chance of success it is still an excellent gamble. So, to sum it up, I am not selling.
Agree with you on this one. The idea that some entity has been holding the price down to slowly accumulate is more than ridiculous. Can't buy more than sell while keeping the price down, and that would be the definition for slow accumulation. CP has been selling this story and some avid longs are apparently buying it.
The street is holding it down, they haven't bought the Bavi story yet.
<< much greater than 50:50 the first line news will be moving the stock down not up.>>
That remains to be seen. Have you joined H4B on the shorts bandwagon? What is your prediction about partnership and the share price within next 3 to 6 months?
Why are you so interested in trendline chart? You know full well that on stock like PPHM news trump technicals big time and news we will have in less than two weeks.
<<FDA would not have approved PHIII if 1st line was not good, IMO!>>
Disagree. P3 has been approved based on the trial results and FDA understands that the results would have most likely been better without the dose switching, close to what was originally reported in September.
First line is crucial IMO, if not very good PPS will take a significant dump and will be hard to partner.
If the first line results are not good they will put the announcement off till the last day of June. If Bavi works great on 1st line then we don't have the trigger point yet and it will be postponed once again.
The IR department sucks, they keep us in dark and that leaves an impression they are hiding or postponing some not so good news they don't want the street to know. Lack of transparency is one of the major reasons the PPS is where it is, not the wild idea they want our shares.
<<"If we have not changed our guidance in a Regulation Full Disclosure format then these timelines are maintained by the company."
This is a conditional statement. A simple Yes or No would be good straight answer. How do you know if they are going to change or have changed the guidance and what would be a delay in such announcement. That guy from IR should quit his job and run for a political office.
You always have an excuse when the shares drop or don't go up. If they are after our shares, as you claim, both the price and daily volume would be considerably higher.
Let's assume this stock is going to 10 or more as many here believe and in that case it really doesn't matter if it is bought at $1.5 or $2. The problem is that the street doesn't believe in Bavi story, not that they want our shares.
The price is low not because they are after our shares, it is low because they are not. The volume tells it all - no buyers. It is hard to put a spin on this very simple fact.
Well, you wrote "we were told...". That makes it sound like it came from the official channels, not from some poster.
OK, that answers my question. Thanks. So, another delay in releasing the results is still possible or probable.
<<It still shows 1st half 2013 on the fact sheet.>>
Yes, we know that. He wrote that we were told on June 5th about the results getting released in two weeks. I do not remember that particular statement. If true than trigger point had to be reached prior to the 5th. I was hoping for another postponement to the next quarter.
<<We were told that it is a fact that front line data would be released in two weeks on June 5th>>
Do you know who made that announcement?