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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?
<<Could it be that people already know the results>>
I would hope for the contrary. However, if we have leak and the results are not great that would certainly explain the drop in share price lately.
<<So, let's hope to see a very strong number in the next two weeks>>
No. I am hoping for another extension.
Looking at the latest hiring one may draw a conclusion that they intent to do it alone. The management may not be satisfied with about 50 to 100 millions upfront money from BP, and I think that's all they will get at this point without having BLA or some sort of accelerated approval path in the pocket.
<<The BP partner is for BAVI. The new hires will advance COTARA :)>>
How do you know this, did you get it from IR? And how many trial managers and other personnel do you need to run a small trial like Cotara, certainly not more than it took for 2nd line NSCLC and all the other trials they ran recently. They should have enough people to run Cotara p3 without hiring.
CP throws another grenade and you all fall for it. Sure, he knows who the author is but won't say. Just like some others know about Fargo but won't talk. Reminds me of kindergarten.
You seem to be pretty confident about a partner in the near future. If they are to get a BP partner with a lot of resources and know how about clinical trials why hire all those trial managers etc.?
<<The June Options are expiring this week and there has yet to be any news released by PPHM>>
June options are not expiring this week, expiration date is June 22. Anyway, I don't see why would option expiration have anything to do with news release. What possible news do you expect this month? First line perhaps but if they move it into the next quarter I will not be disappointed.
<<CSM settlement is in June I believe unless they go to court.>>
Do you know the deadline date for the settlement - is it before or after the June OPEX?
<<Five consecutive days of closing @ $1.66>>
With most biotech down today and the market in red closing @ 1.66 on a low volume is good. We are at the bottom, I added some today at 1.65.
<<How exactly do you know that they didn't PR pancreatic within a few days>>
It is the lack of transparency. They don't say what the trigger point is, so it is an arbitrary set number and they can even change it as the trial progresses. They should say what the trigger number is when the trial starts.
<<we were promised by SK that PPHM would PR if a MOS was reached in one of the clinical trials>>
That should be done within several days - they didn't do it for pancreatic trial.
<<We've closed at 1.66 4 days running. Isn't this a little odd?>>
Looks like the bottom is in barring bad first line results, may be a good idea to add a few shares here or start a small position (ex?). At least H4B hasn't made any money last few days, I wonder if he has covered.
<<I think management has kind of telegraphed that the data is not good>>
If true it will put a serious crimp in partnership talks and in the advancement of bavi. First line or second line, it is the same disease and difficult to explain why would it work better on the sicker patients.
I am hoping to see a large late separation on the KM curve and maybe some complete remissions. That would certainly help with BLA or AA for Bavi.
I don't disagree with you that the fair comparison between Avastin and Bavi is using the same chemo agents and against the control arm. However this is not necessarily what our friends AF, PC and others will do when they spin the results. More than likely they will not talk about Avastin side effects when comparing with Bavi.
The discussion started around PPHM share price and the effect of first line results on price movement. For AF and others to shut up we need to beat all those trials while having MOS considerably above the control arm. That is the only outcome that will convince the street at this time.
Apparently there were multiple p2 Avastin trials with different results, doesn't look to me they were talking about the subset. The MOS numbers are anywhere between 12.3 and 16.7. Can't single out the lowest 12.3 result and compare Bavi against it. We have to be at 18 months while considerably higher than control arm to make a difference.
"The present trial met its primary endpoint of improving median progression-free survival compared with the carboplatin-docetaxel treatment arm in the TAX 326 study (from 4.7 to 7.9 months).15 Moreover, the median progression-free survival in our study compares favorably to E4599 (6.2 months)11 and AVAiL (6.5 months for the bevacizumab 7.5 mg/kg arm, and 6.7 months for the bevacizumab 15 mg/kg arm).17 The median overall survival (16.5 months) was also higher than carboplatin and docetaxel alone (9.4 months in TAX 326),15 and 1 of the highest observed among other platinum-based regimens plus bevacizumab: 12.3 months (for the carboplatin, paclitaxel, and bevacizumab treatment arm in E4599),11 13.4-13.6 (for the cisplatin, gemcitabine, and bevacizumab treatment arms in AVAiL),17 14.1 months (for carboplatin, pemetrexed and bevacizumab, phase 2),18 15.8 months (for carboplatin, nanoparticle albumin-bound paclitaxel, and bevacizumab, phase 2),20 and 16.7 months (for oxaliplatin, pemetrexed, and bevacizumab, phase 2)."
<<you don't understand this..subset/final results...>>
This may be, show me where in the report they say 16.5 months was for a subset. Here is that quote again:
"To date, 27 patients (68%) have had documented disease progression and 23 patients (58%) have died. Five patients (13%) are still on active treatment. The median progression-free survival was 7.9 months (95% CI, 6.0-11.1) (Fig. 1), indicating a statistically significant improvement over the historical control (evidenced by the lower boundary of the confidence interval above the historical median progression-free survival mark of 4.5 months). Median overall survival was 16.5 months (95% CI, 13.6-31.2) (Fig. 1)."
OK, so the p3 Bevazicumab results were a lot worse (12.3) than the p2 (16.5) you referred to in your previous post. I believe, generally, the p3 trials often lag p2 trials in efficacy. So, to convince the street and BP we need to beat the p2 Avastin results which calls for about 18+ months for MOS.
<<We are talking about frontline NSCLC here, not 2nd Line.>>
Don't you think I know that. The world outside iHub board is a lot less optimistic about PPHM and the share price is the proof of that. 25% to 30% may be good for you, maybe even for a BP, but it's not good enough for the street.
<<We need 13.3 months mos minimum on frontline trial that's 4 weeks longer then the Avastin results>>
Well, this is from your link on Avastin trial. Is MOS 16.5?? What' wrong here?
"To date, 27 patients (68%) have had documented disease progression and 23 patients (58%) have died. Five patients (13%) are still on active treatment. The median progression-free survival was 7.9 months (95% CI, 6.0-11.1) (Fig. 1), indicating a statistically significant improvement over the historical control (evidenced by the lower boundary of the confidence interval above the historical median progression-free survival mark of 4.5 months). Median overall survival was 16.5 months (95% CI, 13.6-31.2) (Fig. 1)."
<<I would think that anything in the 20-25% range would be good and anything 25% or above would be great.>>
I strongly disagree. The stock went to $5+ in September after the 100% improvement in MOS was announced, and it is at $1.6 now ($2.5 dilution adjusted) with 60% MOS for NSCLC and phase III approved. Common sense tells you that we need >60% improvement to move the share price. 20 to 25% will do nothing, may even drop the share price.
<<If first line results are great>>
OK, can you put down some numerical information in place of "great". Is "great" 30% better MOS than control, or 50, 100 or complete response?
<<H4B: Merryl Lynch promised me 1 Millon shares>>
Right. And you can get 2 million more to short from a tooth fairy, but you have to be a good boy over the weekend.
<<how high do you think MOS needs to be on this next lung trial to move the pps needle>>
Beat control by at least 80% to really move the stock and/or have some "complete responses". We already have p3 for similar indication with 60% better MOS, so anything less than that will not be perceived as a great result.
I don't know the details about patent protection in medical field, so I can't comment on "the patent clock ticking". However, the first approval makes the drug available off label for other indications. And they are not in better position now, have only one p3 approval for Bavi in NSCLC, could probably had the same for breast cancer a couple of years ago. Bavi is also about saving lives, you don't postpone a life saving drug to go "in rapid fire succession".
<<Strategic reason #1) In order to "continue" buying cheaper future call options.... so the money they lose selling the shares they could gain on the call option>>
The total call volume for June expiration is barely 500k shares. That is peanuts for heavy hitters, it is only retail trading those options. Besides, pros rarely buy options, they write them - that is where the money is but not right now in PPHM case, not enough volume. Most options expire worthless.
You have too much confidence in the management. Garnick is not running the show, SK is.
Bavi has been around for a long time, the first good trial results were out several years ago and instead of pushing for p3 in breast they shelved the results and went to run a number of p1 and p2 for different cancers. We could have been in p3 for breast a long time ago, probably even finished by now had they stayed with that instead of going for everything at the same time. Once you get an approval and the money that comes with it, then you can run trials for other indications while using it off label on other cancers.
Management wasted a lot of valuable time. Transparency is another problem, I haven't seen another company that keeps the shareholders in the complete dark like PPHM does.
north4000, this idea is worth exploring, why don't you or someone else with good writing skills send an email to the foundation. Most of what needs to be said is already in your post.
Main Office
500 Fifth Avenue North
Seattle, WA 98102
(206) 709-3100
info@gatesfoundation.org
<<Cross your fingers for PR, first thing Monday.>>
Wouldn't it be better if the announcement is postponed into the q3 suggesting very good MOS. Patience. Besides, I've sold a boatload of $2 June calls, like to see those expire before we get major news.
That seeking alpha article was from Dec 2012, about 6 months old. Things have changed since then.
Well, you made the right call, can't argue with success. Short term this may go back to 1.5 range.