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stoneroad,
Now that IS interesting. Thanks for that info.
mrpatinmn,
My response to that is very simple. Those that see the dilution as unacceptable risk/reward at this juncture should be selling. They then can wait for the news to be announced and then buy back in. No risk or at least greatly reduced risk. I personally feel that we are very close to a major positive event, that is why I'm staying invested. I would greatly appreciate it if some people could actually train themselves in the psychology of taking a loss and move on. Sticking around claiming to be long invested and trashing the investment on a public board just seems too obviously counter productive for their stated desire of increased stock price. When I was younger I would have said that nobody can really be that obstinate but I've lived too long now and met too many people (including myself introspectively along the way a few times) that, YES there sure are lots of people that stubborn and vengeful.
mrpatinmn,
You're welcome. I am letting the past predict the future and that's why I keep buying the stock.
The list of past events that keep me buying:
1) Outstanding 2nd line NSCLC trial data: FDA approved progression to PIII trials based on PII data that indicated a 60% improvement in MOS. Show me another trial that has better data than this and consider on top of that the numbers were a result our our forced conservatively reconstituted trial population. The world at large will have to make their own assessment of what may or may not have been actually occurring in the trials prior to the incident. My personal opinion is that most of the retail investment and trading world hasn't a clue and could care less. Hence why we need another landmark event to get us going again. Damage done to reputation but not to Bavi's actual efficacy.
2) Outstanding Breast Cancer data from a US IST site that (IMO) shreds all the naysayers claims about the previous MBC data being obtained from questionable overseas sources. >80% ORR rates in a population that typically is only expected to have ~40 something % ORR rates.
3) We have a FDA PIII trial design approved for gliabastoma multiforme orphan drug waiting for a sugar daddy to sponsor it. The company, sad to say, doesn't have the resources to push this any further without seriously compromising the ability to push forward the Bavi platform which in the real world helps more people and represents more money for us stockholders.
4) Steve King is using descriptive statements regarding the liver cancer IST that I don't recall since the 2nd line data descriptions building up last summer to the wonderful data news when the 2nd line was stated to be >100 % improvement in OSS.
5) We've kept ownership control of the entire Bavi IP. Of course at a cost of dilution. I'll take the dilution of the ATM over the alternatives presented here for the purpose of financing product development balanced against the potential returns that I see are still very probable for the reasons in 1, 2 & 4 and item 3 is always waiting to surprise us. Many here have presented very good reasons why dilution is preferable to putting up IP as collateral for loans and for selling it before its ripe or before someone is willing to pony up the dough for a broad based cancer platform that is still playing out regarding its breadth. You've got to remember that Steve hasn't been hedging his adjectives for liver cancer like they were doing for the 1st line NSCLC.
IMO if people cannot see these things as the overriding positives in this high risk speculative biotech world then I'm really at a loss as to why they stay invested in PPHM. At least I'm at a loss for those who say they are invested. I understand there are large short positions in this stock and those people are out to trash it just like we who believe in the potential like to defend it.
Thanks EBS.
Thanks purpledawgs
cheynew,
I haven't been keeping track of the authorized shares left for sale. I've been reading CJ's intro info on this but can't find it quickly; I may be skimming too fast.
Anyway, I thought they had a significant amount left and if they asked for more I was going to be depressed (again). Therefore, I see the non-asking for an increase in the authorized shares to issue as a positive.
I expect the only subjects for a special shareholders meeting (if it ever happens) are to approve the new BOD personnel from the BP for the partnership agreement or to accept the buyout deal. The current BOD has all the power in the world it seems to do everything else that they want to and they are telling us they have all the clout they need until next shareholders meeting. I have a picture in my mind of a big middle finger being flaunted by the PPHM building towards a certain group of people.
cheynew,
My thoughts have always been that we won't get any new BOD personnel until a deal is made and then they will bring the deal to the shareholders with a special meeting if necessary. I don't see them changing their plans just for the annual meeting. Its status quo for PPHM; moving the Bavi platform forward no matter what obstacles arise.
EBS,
The more I think about it, this must be a huge positive. They are confident enough to go all next year without asking for more shares to raise capital than they already have authorized. Must be something in the works for them to be that confident or the trials aren't as expensive as some here have supposed; which I don't think is the case.
Time for a summary of how much we have left in authorized shares to sell if need be. Anyone have that info handy? Thanks in advance.
EBS,
I don't think it is all that bad either; actually not bad at all relatively speaking.
"The total number of shares of common stock that may be issued under the 2011 Plan is currently 11,500,000. If the proposal for the amendment of the 2011 Plan is approved by stockholders, then the Amended 2011 Plan will authorize the issuance of up to 18,500,000 shares of common stock.
At August 22, 2013, we had 941,494 shares of common stock available for grant under the 2011 Plan and our other outstanding stock incentive plans. In order to continue to have an appropriate supply of shares for long-term equity incentives to recruit, hire and retain the talent required to execute our business plans, our Board of Directors is requesting our stockholders to approve an additional 7,000,000 shares of common stock that may be granted under the 2011 Plan. In addition, over the near term, we have insufficient shares of common stock available for grant under the 2011 Plan and our other outstanding stock incentive plans to cover our annual routine broad-based option grant scheduled for May 2014, as further discussed in footnote 1 in the table below.
While adding 7,000,000 shares to the 2011 Plan will increase the potential dilution to stockholders, our Board of Directors believes our equity compensation plans are well-managed and within the median norms for our peer group. We expect that with the additional 7,000,000 shares for which we are seeking stockholder approval, we believe we will have sufficient shares for our equity compensation program for at least two fiscal years based on our historical three-year average run rate for stock option grants, excluding any non-routine broad-based grant of stock options as discussed in footnote 2 in the table below. If the amendment to the 2011 Plan is not approved by the stockholders, share-based awards will continue to be made under the 2011 Plan and other outstanding stock incentive plans to the extent shares are available."
rekorb,
Thank you for that spreadsheet. I find it very interesting.
ImaPseudonym,
Never mind my bad. You are right. I have deleted my message.
ex,
I posted months ago IR's response to my query for clarification on the disconnect remark. Here again is that exchange. Anyone obviously can choose to believe it or not. However, its easy enough for anyone here to send their own email to Chris Keenan (the address is in the exchange below)to confirm. Note: I have removed my identifying information, other than that you have the whole exchange below.
It starts with the body of Chris Keenan's reply to my question lower in the thread
Jake, is there any realistic option that may be employed by stockholders to change this situation?
geocappy,
Then your goals for this discussion thread succeeded I believe. Good job.
geo,
If I remember correctly it was for the reason that FTM stated. They chose not to include squamous not because Bavi was ineffective on squamous cell tumors, it was because the nature of the tumors for squamous are typically/mostly/almost always(??) associated with locations adjacent to/surrounding major arteries and/or veins. This characteristic causes higher risk for treatments that effect the blood supply to tumors, the way Bavi and Avastin do, because these types of treatments are known to have caused harmful bleeding reactions during treatment for these types of tumors. Its as FTM said, it was to reduce the risk of adverse events occurring in the trial. I'm doing this from memory but it lines up with what FTM said.
lorekarf,
I posted a response to lame attempt at a listing of NSCLC drugs that any one of them were, in that poster's opinion, better than Bavi for NSCLC.
One of them was BMS's PD-1 drug BMS-936558. Here is on of the links for trial data on that drug:
http://www.hematologyandoncology.net/index.php/supplements/highlights-in-nsclc-from-the-2012-chicago-multidisciplinary-symposium-in-thoracic-oncology/
My read of the data for the BMS drug and Bavi's data were almost on equal footing. One thing to note is they (BMS) had 120 patients enter their trials and Bavi only had 41 (the handicaps of being a poor small cap biotech). It should also be noted how many of those 120 BMS trial patients made it to being evaluable; 76. Not a whole lot of difference there IMO between the Bavi and BMS PD-1 drug trials - percentage wise - though slightly in BMS favor.
A favorable item on the BMS side is that they included Squamous cell patients and had a 33% ORR for them. But on the negative side for them (especially when comparing directly to Bavi's trial data), only had a 12.5 % ORR for the non-squamous population - advantage to Bavi at 17 % (if not handicapping the smaller Bavi trial size; which I'm sure the professional anti-Bavi crowd will be wont to do).
There was only PFS data to 24 weeks for BMS. Bavi has long term survival data to 29 months. I don't know enough of the Bavi data makeup (such as how many are actually alive at 29 months) to outright declare that a ringing advantage for Bavi but in comparison it certainly appears to be a big unknown for BMS's drug; especially if trying to use ORR as a surrogate for long term survival. We actually have a 29 month plateau, what do they have?
Bavituximab, the Rodney Dangerfield of Biotech.
I see the link doesn't take you directly to the article. Here is the info I extracted (you can create an account for free and access the article):
Clinical Activity and Safety of Anti-PD-1 (BMS-936558, MDX-1106) in Patients (Pts) With Advanced Non-Small-Cell Lung Cancer (NSCLC)
The safety population of 120 new patients had a mean age of 65 years, and most were men (61%). Patients were divided between squamous cell histology (39%) and nonsquamous cell histology (60%). Most patients had good ECOG PS (0 for 34 patients, 1 for 83 patients, 2 for 2 patients, and not reported for 3 patients). The number of prior therapies was 1 for 18 patients, 2 for 31 patients, 3 for 27 patients, and 4 or more for 40 patients. Platinum-based therapies had been administered in 94% of patients, and 34% had received a prior tyrosine kinase inhibitor.
BMS-936558 was generally well tolerated. AEs occurred in 64% of NSCLC patients. The maximum tolerated dose was not found. At the doses of up to 10 mg/kg included in this study, no relationship was apparent between dose and AE frequency. In the NSCLC patients, the common drug-related AEs were fatigue (18%), decreased appetite (10%), anemia (8%), nausea (7%), pyrexia (6%), and diarrhea (6%). Such events were consistent with the immunogenic activity of BMS-936558. Grade 3–5 related AEs occurred in 8% of the NSCLC patients. In patients with NSCLC, fatigue was the most common grade 3/4 toxicity (2% of patients). Grade 1/2 pneumonitis occurred in 6 (2%) patients, including 4 (3%) NSCLC patients. Among the patients with pneumonitis, 3 drug-related deaths occurred (2 patients with NSCLC and 1 with colorectal cancer).
Among the 76 patients with NSCLC who were evaluable for clinical activity, the ORR was 18% (Table 2). There were 14 cases of PR, which occurred at doses of 1 (1 of 18 patients), 3 (6 of 19 patients), and 10 mg/kg (7 of 39 patients), resulting in response rates of 6%, 32%, and 18%, respectively. Two additional NSCLC patients who had received the antibody at a dose of 10 mg/kg were awaiting a confirmatory scan, and thus had unconfirmed PRs.
The anti-PD-1 antibody was active in both squamous and nonsquamous NSCLC histologies. Responses occurred in 6 of the 18 patients with squamous histology (33%) and in 7 of the 56 patients with nonsquamous histology (12.5%). All 14 of the responding patients began treatment more than 24 weeks before the analysis, and 8 of these patients had a response that lasted 24 weeks or longer. Further, 3 patients had a persistent decrease in overall tumor burden in the presence of new lesions, so they were not classified as responders.
BMS-936558 can be administered safely in heavily pretreated NSCLC patients in an outpatient setting. BMS-936558 is well tolerated. The clinical activity of BMS-936558 in patients with previously treated, advanced NSCLC is encouraging and warrants further development of this agent in patients with advanced NSCLC.
Carboat,
Leave it to you to imply Roth is a liar. Its not Roth's status in the industry that matters here, its the information that Roth provided - specifically no questions by the FDA regarding the most contentious part of the trial data presented (i.e, the combining of the control and Bavi arms to arrive at a new control group for the blinded trial). If you have proof that Roth provided false information on this subject, please provide it.
I doubt that you will be able to provide proof because to me its obvious that you take no missed opportunity to TWIST a story - and you're not even that good at it.
Just revised (in italics) an important point to make it clear what wasn't questioned by the FDA.
Bio,
Thanks for the link. Now because of the following from the Roth report link:
Bio,
My time in China last year and my interfaces with the projects since then certainly back up statements regarding the knock off industry going full bore there. We haven't even finished starting up the first nuclear plant of the type I was working on and they are already marketing their Chinese copy to foreign markets. Those guys are the epitome of "no moss growing on my ass" capitalist.
I passed a Pharmaceutical district every day to and from work and the hotel. There were drug companies as numerous as the fleas on Loof's dog. I know they must have a huge knock off industry going on in drugs. I always wondered how much of the PPHM IP they had their hands on and what they were doing with it. I don't think patent laws are big on their list of things they need to watch out for when doing business.
Sorry Bio if this post is not on topic of the moment but I'm catching up from yesterday evening and have just started.
Bio,
Does this link help:
http://caps.fool.com/Blogs/who-is-kenneth-b-dart-and-why/388891
Stockharvest,
The best and quickest way to get the information you seek is to un-hide the intro section to this board (if you have it hidden) and just do a word search on "patent". There is a load of information on this subject there. Our intro section has a lot of great info thanks mostly to our great data king CJGaddy. He's like the Librarian from the movies. Happy reading and welcome to the carrousel.
Ex,
With all due respect your question was:
"So my question is, what is the factual basis of this deep respect?"
If you don't believe that by being the regulatory/compliance point man (i.e., the senior vice president of regulatory, quality and compliance) for shepherding the monoclonal antibody therapeutics Rituxan, Herceptin, Avastin and Lucentis through to FDA approval is not deserving of great respect in the pharmaceutical/biologics industry, then its my contention that your intention was as I thought it to be; you only wanted a soapbox reason to diminish the significance of having an industry heavyweight on our team. A heavyweight in our specific product area by the way.
You really can't be serious? However, I'm sure you'll provide quite rational (in your opinion anyway) reasons why he isn't deserving of great respect. After all its an obviously subjective question that allows anyone to answer with any type of self interested bias that they choose to apply to the response. At least my response was backed up with facts.
Sorry in advance to all the serious longs here for letting him have another shot at this. But, doesn't it just stretch credulity for someone not to accept Dr. Garnick's experience as a basis for deep respect in our specific corner of the pharmaceutical industry?
Ex, it certainly seemed obvious to me that my response was more than sufficient to answer your question and I would think that most people reading this board would agree.
ex,
I'm curious why you would even ask that question. I wouldn't think that you would pretend to not know the credentials of DR. Garnick so I'm left wondering why you would ask that question.
Is it just a setup for you to diminish his accomplishments and qualifications? Let's see where you take this.
In response to your question:
"During his 24-year career at that company [Genentech], he was responsible for 17 new product approvals, including most of the company's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin and Lucentis."
"Rob has an unparalleled track record in the biotechnology and pharmaceutical industry, having led the regulatory, quality and compliance strategy for developing many of the most successful monoclonal antibody therapeutics currently on the market representing multiple disease areas,"
jbainseky,
Thank you for that link. That is a very good reference document to have. I've been looking for some information all over the FDA site this morning with little luck. Then I see this post I easily find references embedded in it that provide the information that I've spent several hours looking for. Amazing how things turn out sometimes.
Dew,
You have not come anywhere close to supporting your assertions. I've given up after checking out the first 6 links. You are 0 for 6 in your assertion that these drugs are better than Bavi. I'm sure you will come back with further excuses limiting the application for the drugs to make your case but as I am providing below everyone can search the links and see your assertion is false.
Response to 1st and 2nd trial links (same drug):
BMS-936558
http://seekingalpha.com/article/296295-bristol-myers-squibb-zeroes-in-on-a-blockbuster-cancer-drug
9-27-11
“With respect to efficacy, BMS-936558 has not been evaluated in large, randomized trials, but it still generated impressive signs of efficacy in multiple indications. The extent of this effect appears superior to what Yervoy demonstrated in early stage trials. Data presented last year at ASCO included a 30% response rate in patients with late-stage melanoma or renal cancer, which is very unusual for a single agent. BMS-936558 also had an intriguing signal in lung cancer with a response rate of ~10% and disease stabilization in an additional 40% of patients. It is important to note that response rate is believed to under-represent activity of immunotherapies, as they tend to be more subtle, with durable, long-lasting effects even after discontinuation of treatment.”
Hey Dew, were you sitting on the bolded italicized info when you were slamming the top line data early last year for the PPHM 2nd line NSCLC. Can you say hypocrisy?
From: http://www.hematologyandoncology.net/index.php/supplements/highlights-in-nsclc-from-the-2012-chicago-multidisciplinary-symposium-in-thoracic-oncology/
Clinical Activity and Safety of Anti-PD-1 (BMS-936558, MDX-1106) in Patients (Pts) With Advanced Non-Small-Cell Lung Cancer (NSCLC)
The safety population of 120 new patients had a mean age of 65 years, and most were men (61%). Patients were divided between squamous cell histology (39%) and nonsquamous cell histology (60%). Most patients had good ECOG PS (0 for 34 patients, 1 for 83 patients, 2 for 2 patients, and not reported for 3 patients). The number of prior therapies was 1 for 18 patients, 2 for 31 patients, 3 for 27 patients, and 4 or more for 40 patients. Platinum-based therapies had been administered in 94% of patients, and 34% had received a prior tyrosine kinase inhibitor.
BMS-936558 was generally well tolerated. AEs occurred in 64% of NSCLC patients. The maximum tolerated dose was not found. At the doses of up to 10 mg/kg included in this study, no relationship was apparent between dose and AE frequency. In the NSCLC patients, the common drug-related AEs were fatigue (18%), decreased appetite (10%), anemia (8%), nausea (7%), pyrexia (6%), and diarrhea (6%). Such events were consistent with the immunogenic activity of BMS-936558. Grade 3–5 related AEs occurred in 8% of the NSCLC patients. In patients with NSCLC, fatigue was the most common grade 3/4 toxicity (2% of patients). Grade 1/2 pneumonitis occurred in 6 (2%) patients, including 4 (3%) NSCLC patients. Among the patients with pneumonitis, 3 drug-related deaths occurred (2 patients with NSCLC and 1 with colorectal cancer).
Among the 76 patients with NSCLC who were evaluable for clinical activity, the ORR was 18% (Table 2). There were 14 cases of PR, which occurred at doses of 1 (1 of 18 patients), 3 (6 of 19 patients), and 10 mg/kg (7 of 39 patients), resulting in response rates of 6%, 32%, and 18%, respectively. Two additional NSCLC patients who had received the antibody at a dose of 10 mg/kg were awaiting a confirmatory scan, and thus had unconfirmed PRs.
The anti-PD-1 antibody was active in both squamous and nonsquamous NSCLC histologies. Responses occurred in 6 of the 18 patients with squamous histology (33%) and in 7 of the 56 patients with nonsquamous histology (12.5%). All 14 of the responding patients began treatment more than 24 weeks before the analysis, and 8 of these patients had a response that lasted 24 weeks or longer. Further, 3 patients had a persistent decrease in overall tumor burden in the presence of new lesions, so they were not classified as responders.
BMS-936558 can be administered safely in heavily pretreated NSCLC patients in an outpatient setting. BMS-936558 is well tolerated. The clinical activity of BMS-936558 in patients with previously treated, advanced NSCLC is encouraging and warrants further development of this agent in patients with advanced NSCLC.
Summary: can’t find any published MOS data for this drug in a 2nd line NSCLC trial. Throwing the BS flag.
Response to 3rd trial link:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3429597/
Oncoimmunology. 2012 August 1; 1(5): 791–792.
TG4010:A therapeutic vaccine against MUC1 expressing tumors
“This open-label study recently published in The Lancet Oncology enrolled 148 patients with stage IV NSCLC, 74 received cisplatine and gemcitabine plus TG4010 and 74 received the same chemotherapy alone.”
“With 43.2% of patients progression free at 6 mo in the experimental arm this second Phase II in NSCLC met its statistical endpoint too. In the control arm 35.1% of patients remained free of progression at 6 mo. Interestingly the magnitude of the improvement was more important on response rate: 41.9% vs. 28.4%. Furthermore the outcome in terms of survival of responding patients in the experimental arm was better than in the control arm (23.3 vs. 12.5 mo). This observation is similar to the better duration of response observed in melanoma patients receiving dacarbazine plus ipilimumab as compared with dacarbazine alone.7 Regarding overall survival the median survival in both arms were similar, 10.7 mo vs. 10.3 mo however a late separation of the curves, classic with immunotherapy products showed a better long-term survival for the experimental arm. Conversely more patients died early in the experimental arm.”
See the following link for more info on MUC1 expression:
http://clincancerres.aacrjournals.org/content/6/5/1917.full
Summary: Not better than current Bavi data and limited to population of MUC1 expressing tumors. I’m throwing the BS flag on this one too.
Response to 4th trial link:
insert-text-here
Pharmgenomics Pers Med. 2012; 5: 113–123.
Published online 2012 September 25. doi: 10.2147/PGPM.S24258
PF00299804 is a pan HER inhibitor, targeting EGFR, HER2, and HER4. In preliminary studies, it has been shown to be effective in patients with EGFR mutations in the first-line setting.70 In a randomized Phase II study comparing it with erlotinib in patients with NSCLC following progression on chemotherapy, an overall PFS advantage was achieved.71,72 A phase I/II study of this agent in Asian patients who were refractory to chemotherapy and erlotinib or gefitinib, showed antitumor activity without significant toxicity.73 Further studies with this agent are pending.
EGFR Data from this link: insert-text-here
EGFR has been previously shown to be dysregulated in NSCLCs by protein over expression, gene amplification, or mutations [8]. In unselected NSCLCs, EGFR mutations are found in 10% of cases from North America, western Europe, but are reported in 30–50% of patients of East Asian descent and mostly (> 50%) associated with adenocarcinomas with bronchoalveolar features that arise among non-smokers [9–13].
HER 2 Data from this link: http://www.mycancergenome.org/content/disease/lung-cancer/her2
HER2 mutations are detected in approximately 2–4% of NSCLC (Buttitta et al. 2006; Shigematsu et al. 2005;
HER1 Data from this link (need to read if you want to assess it because the data is on a slide image; expressed in 43% of large cell non-squamous NSCLC):
http://www.mesothel.com/asbestos-cancer/related-disease/non-small-cell-lung%20cancer/nsclc_HER1_EGFR.htm
Summary: Throwing the BS flag - again. Dew has been penalized on every play so far.
Response to 5th trial link:
http://www.ncbi.nlm.nih.gov/pubmed/22753918
Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer.
PURPOSE:
This randomized, open-label trial compared dacomitinib (PF-00299804), an irreversible inhibitor of human epidermal growth factor receptors (EGFR)/HER1, HER2, and HER4, with erlotinib, a reversible EGFR inhibitor, in patients with advanced non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS:
Patients with NSCLC, Eastern Cooperative Oncology Group performance status 0 to 2, no prior HER-directed therapy, and one/two prior chemotherapy regimens received dacomitinib 45 mg or erlotinib 150 mg once daily.
RESULTS:
One hundred eighty-eight patients were randomly assigned. Treatment arms were balanced for most clinical and molecular characteristics. Median progression-free survival (PFS; primary end point) was 2.86 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (hazard ratio [HR] = 0.66; 95% CI, 0.47 to 0.91; two-sided P = .012); in patients with KRAS wild-type tumors, median PFS was 3.71 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (HR = 0.55; 95% CI, 0.35 to 0.85; two-sided P = .006); and in patients with KRAS wild-type/EGFR wild-type tumors, median PFS was 2.21 months for patients treated with dacomitinib and 1.84 months for patients treated with erlotinib (HR = 0.61; 95% CI, 0.37 to 0.99; two-sided P = .043). Median overall survival was 9.53 months for patients treated with dacomitinib and 7.44 months for patients treated with erlotinib (HR = 0.80; 95% CI, 0.56 to 1.13; two-sided P = .205). Adverse event-related discontinuations were uncommon in both arms. Common treatment-related adverse events were dermatologic and gastrointestinal, predominantly grade 1 to 2, and more frequent with dacomitinib.
Summary: Limited application and results not as good as Bavi. Throwing the BS flag - again. My arm is getting tired already. Dew must train with the Raiders.
Ponatinib for Squamous Cell Lung Cancer
For Squamous Cell Lung Cancer – need more be said?
http://lungcancer.about.com/od/glossary/g/squamouccell.htm
"Squamous cell lung cancer is a form of non-small cell lung cancer. Eighty percent of lung cancers are non-small cell lung cancers, and of these, about 30% are squamous cell."
Already approved for chronic myeloid leukemia but after reading the following link the safety profile doesn’t appear to be anywhere near that of Bavi and as stated it has a limited PROJECTED application in NSCLC. No PII trial data yet that I can find.
http://www.ariad.com/about_iclusig
Summary: BS flag thrown for the last time tonight. None of these are even close to bettering Bavi for breadth of application and magnitude of results. Dew apparently isn't playing by the rules; he’s posting bad info; again.
Thanks 4Our. Actually I've heard that before but had completely forgot about it. It's probably because when Friday afternoon comes my mind is already on weekend chores and how to avoid them.
Carboat,
You really believe you've proved your point?
Again he stated:
"Having personally been involved in the evaluation of over 30 Phase II trials over my career, none of which ever achieved statistical significance, including many of today's blockbuster biotech products,..."
Prove that any of his 30 phase II trials achieved what he would describe as statistical significance.
Carboat,
Maybe you should look up the definition of impropriety before you embarrassingly claim something is from your head:
1: an improper or indecorous act or remark; especially : an unacceptable use of a word or of language
2: the quality or state of being improper
The impropriety here is your response to aikifredicist.
Lets take them one at a time:
Rampant ATM usage: Covered many times here on the board and I'm sure you are well aware of that the logic for using the ATM (so I'm sure you are well aware of this logic but choose to ignore it) is that it is the most widely acceptable lesser evil. Why do you never provide reasonable alternatives as to how the company should obtain investment capital? The ATM is the lesser of all the evils available especially after the incessant, and to date successful, bashing campaign I've seen on this board since around 2004-05 time frame. What's improper about using the ATM? Maybe they should get a loan and put the IP up as collateral and watch it disappear when the company is driven into bankruptcy by an act of sabotage in a CRITICAL trial that was going gangbusters until the "DELIBERATE DOSE SWITCHING" was discovered. Maybe you ought to also review the definition of what "deliberate" means while your at it. The company used the least risky method to protect the ultimate value of the company and therefore, the ultimate value available to the shareholders, while balancing the costs against protecting the ownership of the intellectual property. Where is the impropriety in that? Well of course the answer is there isn't any.
Never seen a statistical significant phase II: This proves beyond any doubt to me that you are here to only generate negative press no matter what. I'm so glad I posted a link yesterday to a video on the design of clinical trials. In this video it is QUITE clear that the purpose of PII trials is NOT to generate statistically significant data. For all those who want to see this here is the video link (sorry about the boredom that comes with watching it but if you are any type of newbie in investing in this type of company, it sure would behoove you to watch it):
investingdog,
You forgot to add the 1,000,000 ton meteor strike on PPHM headquarters in Tustin
The following is link to a presentation on the design of clinical trials:
Wook,
Thanks for the IR call and posting the info. In my book you are one of the guys on good side.
As far as the frustration with how PPHM management is handling the sabotage (go ahead and challenge me on the use of the word sabotage; on this issue CP is absolutely correct and I could care less what you anti-sabotage word usage people think)I also feel the frustration in a very big way.
However, what is more important to the bottom line of the stock price?
a) Getting into a long drawn out legal battle with CSM on this issue with all the associated costs (which will definitely be relatively significant for us); also the very negative impact of going into our MOST CRITICAL FDA MEETING EVER - to date - with a hostile CRO and trying to obtain approval from a very non-standard presentation of trial data for which to my understanding requires the CRO to be very cooperative to back up the trial data reconstitution effort/results that we are using to justify progressing to PIII. How could we justify creating a hostile relationship with one of the most critical participants to support or PIII presentation and advancement? What would we possibly get out of it that could justify this? We get the 10 million from the insurance company (suggested on this board as standard insurance coverage for this type of company) only after years of legal issues; what the hell is that worth against the risk of not getting PIII approval because CSM goes into a shell and lawyers up? Do you think we can end up owning the CRO company? Highly unlikely that will actually happen and I'm sure it won't be worth a dime by the time it happens. This route makes no sense to me.
OR
b) Find the best way to get Bavi to PIII trial approval and getting the investment political capital and goodwill that comes with the FDA saying that we can go to PIII.
There is in my opinion very little upside to pursuing CSM in a hostile manner, especially at this point in time.
I am just as pissed off as any of you who lost money but I don't see the path of going after CSM - in a very aggressive ball busting "we are going to take you to the cleaners manner" - at this point in time, as being anything but a HUGE mistake.
I'm sure CSM knows how much we need them to get a successful outcome of the end of PII meeting with the FDA. I believe they must see an opportunity to help reduce their liability in some way by trying to help us minimize our damages. To those of us who continue to believe in the Bavi platform and continue to hold stock, our damages are more than the current stock price, the most important to those of us who hold PPHM stock is the continued ability of PPHM to progress the Bavi platform.
For those of you who sold - and I certainly can't blame you if you did - I guess we are just going to have to be on opposing sides of this issue if you think the only way to get compensation is through lawsuits.
The best way forward IMO is for CSM is to help us get FDA PIII approval and support the data for 2nd line NSCLC as being as groundbreaking an improvement as the PPHM position says it is.
I would please like to hear from any rational opposing view how alienating the CRO at this critical point in time in any way is going to benefit the company, the continued stockholders or those who lost money permanently because they have already sold.
Thanks. Sorry this post is not checked and a bit wordy but I'm in a hurry and have to go. I'll read responses later tonight if there are any.
Ex,
Thank you for your response, it is appreciated.
Bravo Zulu CJ. Much appreciated and just emphasizes how much relevant info has already been hashed out here. Too bad we don't all have photographic memories (or paid memberships to allow searching) to help you out. Its sure nice to have you batting lead off for us.
You are welcome Bungler. I'm glad you didn't get upset with my interposing myself in this discussion. This censoring issue is kept alive here and I don't mind that. We need to deal with facts on these important subjects, if facts are available.
Carboat,
I'll impose myself into this discussion if you don't mind; after all it is an OPEN message board. I was involved in this same line of discussion almost 2 months ago with exwannabe in post 112963. Ex never responded so I let it drop. But the issue keeps coming up.
First, I'll answer your question which was
Goodbye Dr. Thorpe
Dr. Thorpe!… Dr. Thorpe!!!!,
where are you going…
why such a hurry…
you forgot your Things!
Can’t say… but for sure I’ve no choice in the matter,
Urgent business as usual and
for this business only a memory of my Things is needed.
The Things are yours now
Please use them well,
I hope they help ease your travels someday…but
I must be off on mine; goodbye.
Thank you Sir,
Goodbye Dr. Thorpe.
Thanks for the advice CP.
CP,
Thanks for the response, its much appreciated. I'm just trying to figure out how this issue is going to screw us. I'm just paranoid; well maybe "conditioned" is a more appropriate term after experiencing these bear raids so many times.
CP,
I'm very inexperienced with options. Never have used them.
However, this discussion is very interesting. Anytime something unusual like this occurs for this stock a person really needs to take notice-IMO.
What if a person wanted to own the shares for a nefarious purpose such as to support a continued downward trend during a bear raid.
I'm thinking that the person might want the shares to continue a bear raid initiated with short positions and to continue the downward pressure by selling a huge block after the circuit breaker rule kicks in to prevent more short positions from being entered.
Does this scenario have any credibility or possibility in your opinion?
Thanks CP.
Probably true. After all the ones who get to make the manpower decisions are usually the managers, admin and HR departments and I'm sure they never believe they are overstaffed in those areas so it must be the rank and file functional departments for the organization they support. Peregine-Bavi-Cotara (That's to keep in the TOS).