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<< Likely we here about update 2nd NSCLC investigation next month.>>
No. Per PPHM "we expect to report data from the pancreatic trial during the first quarter of 2013, and data from the first-line NSCLC trial during the first half of 2013."
In some of your posts you say the longer we wait the better. Are you losing your patience or is "Frustrated" getting the best of you?
<< I would think this would be pretty much known at this point as these trials are open label. >>
Correct, and we expect good results but market reaction and PPS can really be wrong going into the binary event.
The best last example is KERX and I don't know how many here are familiar with it so I will say a few words. The kidney disease drug, Zerenex, passed p3 trial previously in Japan and positive results from the other longer p3 trial here in US was almost a sure thing. Yet the stock was stuck just below $3 facing binary event, and several days ago went up a bit on a leak. The p3 results were announced two days ago and KERX closed today at $8.36 or 3 times higher than where it was on Jan 18. Given that the expectation or probability for positive result was at least 80% how can we explain 200% gain in price after the announcement. It doesn't make any sense, should have gone up about 20% or so. I couldn't believe market was so wrong, so I sold too early at 6 for 100% gain. Same thing happened to few other biotech stocks on my radar screen and one has to come to the conclusion that PPS going into binary event is deliberately kept down by shorts, MMs or others who want to get in at the rock bottom prices etc.
This is most likely the case with PPHM too, price went over $2.50 on Jan 7, and it is down to $2 today while the fundamentals haven't changed or actually got better based on better MOS expectation with more elapsed time.
<< Surely Big Pharma knows the data results by now >>
Not necessarily, if MOS hasn't been reached they don't know, or don't know enough. Nobody is going to throw billions at PPHM unless almost absolutely sure about Bavi efficacy. You just gonna have to wait, like the rest of us. BP may know more but not enough to make commitment. They may want to wait till the first line NSCLC trial data become available and that may be 6 months out.
<< Did someone tell the shorts that their safe for the next two months? >>
Shorts are not responsible for this slow PPS decline. It is the low volume that allows market makers to churn shares with no buyers to interfere - happens all the time. Better get used to this - it may continue till the end of this quarter or even longer if MOS for pancreatic cancer is good, hence no endpoint. I guess we will have to wait a couple more months for Loof Korn Licker Classic winner. I can't see anything happening till the MOS is announced - probably by the end of March. Patience, and if you believe in Bavi science hang on to your shares, all IMHO only.
<< pitiful close and volume drying up! still holding shares but i think $1.80 is coming in a week or so >>
Sure, no buyers in the absence of news. That has been expected. One could sell some and buy it back for 10 to 20% less or sell Feb $2 covered calls but it is a risky proposal - could miss the boat.
<< Best of Luck and Data! >>
Well, we will have to wait for data. Just got reply to my email from Investor Relations - nothing new. PPHM expects to report data from the pancreatic trial during the first quarter of 2013, and data from the first-line NSCLC trial during the first half of 2013. So, probably nothing till March, and by that time PPS could be down another 10% or more. Yea, I know, the suspense is killing us, so is the share price.
They will break $2. To use your language they were first banging their heads on 2.25, then 2.15 and now 2. PPS will continue to slowly go down till we get some data.
<< Couldn't/Shouldn't PPHM PR confirming MOS not achieved? >>
I sent an email to PR on Friday, this was one of the questions. No reply yet.
<< IMO the MOS for the pancreatic trial has already been reached >>
MOS is a material event, it should be announced.
<<what happens when the MM gets caught holding the bag?>>
It doesn't happen. They will almost always be fully hedged. They make their money on spread, not by taking the risk.
<<The company will have liability insurance with a limit. Which may be in the millions.>>
Millions will not be enough even to cover market cap loss. In addition we have dilution, default on the loan, delay in p3 or another p2 trial, delay in FDA final approval etc. This could easily bankrupt CMS if it turns out they are responsible and there is no set limit for damages in the contract in case of errors like those.
75k is just a nominal amount. The real damages to be determined during the trial.
<<what this "trading" in the same minute and the same second with the same volume is telling you?
Market Maker doing his job matching buyer with seller, eh? >>
Churning shares, standard operating procedure to slowly drive PPS lower. There should be a very small federal tax on every transaction, like they have in some other countries. That would quickly stop that sort of manipulation.
<< I say we go through $2.22 today.. >>
Based on what? The stock will most likely continue to drift down slowly till we get some news. So, if we hear nothing till 3/4/13, which is the median value in the contest, the PPS is likely to drift down to about $1.60. And if we get in March with no news and price below $2 it will be a strong buy based on very good MOS in the other p2 trials.
<<since they tested 8000 vials (166 per patient)>>
They had 120 patients, 40 in each group - correct me if I am wrong.
8000 / 120 = 66 vials, not 166.
Loofmans PPHM Korn Licker Klassic median date
FWIW median date is 3/4/13.
You might be right. Don't know why you picked 1.84 as your limit price. Looks like the new trading range will be around $2.
No, we don't want to have any news tomorrow, or day after tomorrow, or for next sixty days. Two more months without having MOS results for the other p2 trials would be great. Patience, every day without news is a great day.
<< More ways to steal money from the little guys. >>
Well, it is justifiable for expensive stocks. GOOG is going for about 750 bucks, so one standard contract or hundred shares would require 75K to execute. Sure, they want to get more commission money - nobody forces little guys to trade options.
<< Hey, I see mini-options are scheduled to start March 2013!!! Maybe I try them then!!!>>
Yea, you can but not PPHM. Only five securities initially - see below.
NEW YORK, November 26, 2012 - The International Securities Exchange (ISE) today became the first exchange to confirm a launch date of March 18, 2013 to commence trading in Mini Options. Since receiving Securities and Exchange Commission (SEC) approval for this innovative new product offering, ISE has been coordinating with its member firms to determine an appropriate date for launch readiness. Mini Options will represent a deliverable of 10 shares of an underlying security, whereas standard contracts represent a deliverable of 100 shares. ISE will initially list Mini Options on the following securities: APPL, AMZN, GLD, GOOG, and SPY.
<< he talks about the negative volume (actually decrease in volume). Good sign according to chartists. >>
PVI and NVI indicators are based on the assumption that the smart money dominates trading on quiet days and that the crowd dominates trading on active days. So, it is a good sign and like most TA it is a lagging indicator. More useful for indices than individual stocks.
<< now my questions are of not your concern. >>
I believe the board is here to share information. You certainly took advantage of other posters like FTM etc. to learn more about Bavi, clinical trials etc. This is a two way street, everybody should contribute.
They don't have 236K shares, that's the value of investment. They have 111k shares, hardly significant.
Thanks wookie. I am just trying to learn more about all this. So, if I got it right, the prevailing opinion is that in the beginning you don't see much shrinkage in solid tumors due to the inflammation etc. Now, we believe that patients on Bavi live longer - does it actually shrink tumors with time, slows down tumor growth or prevents new mets from starting all over the body?
Thanks, reasonably good answer.
CP <<that article didn't sit good from the very first time I read it>>
True, the tone is negative, it almost sounds he knew more than he was willing to say at that time. However he brings up some valid questions.
Quote:
"Survival is a hard endpoint to fudge -- a patient is either dead or they're not -- so fabricating survival results isn't the biggest concern. I'm more worried about Eastern European or Indian doctors enrolling lung cancer patients who haven't yet truly failed first-line therapy and therefore shouldn't be eligible for the second-line bavituximab study."
Peregrine should reveal the response and survival in USA and compare with India and Eastern Europe for 3mg Bavi. They haven't done it, or at least haven't announced it. - why?
And another one:
"Initial results from this front-line lung cancer study were released last March, and they weren't positive. The tumor response rate in the bavituximab arm was 25% compared to 23% for the control arm; progression-free survival was 6.7 months for bavituximab vs. 6.4 months in the control arm -- a difference of just nine days."
I would really like to hear an explanation for this from some more knowledgeable posters.
If one really wants to buy for 10% less the alternative approach to waiting for a pullback is to buy the stock and sell Feb $2.5 covered calls. Sure, the gain is limited to about 60 cents if the stock takes off before Feb 15 (option expiration). Than again if no news by that date one would lower the purchase price by about 10%. In any case making 60 cents on a $1.90 investment in less than a month is not a bad deal even if the stock gets called away.
<<However, the cleaning person can be ruled out :) I know as much as that (unless of course if he/she brought her own printed and coded labels :)>>
We are just speculating but sabotage can also be done by switching contents of the bottles and vials containing Bavi or placebo, diluting, mixing etc. without even touching the labels.
Since we are discussing the conspiracy theory would anybody want to speculate as to what organization or individual may be in a position and have resources to organize the sabotage. BP, Hedge fund or an individual? How about a mole in PPHM?
CP, you have to reach across English Channel and bring Sherlock Holmes in.
Now, on a more serious note, only one corrupted person could switch samples, vials or labels, possibly at the shipping department, or a cleaning person after everybody else has left.
Watch it, Loof,
You gonna have animal protection agency go after you. LOL
CSM hiring -
http://general.jobshq.com/search/page/details/job/397818/
http://csmondemand.com/pdf/PMAJobPosting_070722010.pdf
Business must be good. Any takers?
OK, thanks for the explanation. I am new here, got in after the coding fiasco, so I am not very familiar with the details about the events that took place in the past. Got relatively large position (for me) and have to justify my investment choice, hence the questions. Nice board, much appreciated.
CP, out of curiosity, how long have you been invested in PPHM?
<<FDA made them re-start from phase I because a more effective dual catheter delivery system had been adapted as a standard >>
Are you telling me FDA reversed it's decision on p3 for Cotara and made them go back to p1? This had to be a hard pill to swallow.
This is all great but it doesn't explain what happened with P3 Cotara clinical trial that was approved in 2003. I do not want to jump into conclusion, but it looks like they haven't been interested in running p3 trials. Same thing happened several years ago with breast cancer, King said the response was really good, never went to p3 trial. They started working on other cancers etc. - one has to question the management decisions, or worse - lack of confidence Bavi can achieve stat sig results in p3 trials. Then we have double blinded relatively large p2 lung cancer trial with coding errors so it can't go to p3 trial again. Too much of a coincidence for me to feel comfortable holding a large position. Something could be rotten in the state of Denmark.
Cotara p3 trial approved in 2003
Peregrine Pharmaceuticals Receives FDA Approval for its Cotara(TM) Phase III Registration Trial Design for Brain Cancer
TUSTIN, Calif., Feb 24, 2003 /PRNewswire-FirstCall via COMTEX/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start its Cotara Phase III registration clinical study in recurrent glioblastoma multiforme (GBM). The approved clinical protocol is designed to rigorously evaluate the safety and efficacy of Cotara in a multi-center clinical trial. This single trial will be sufficient for the FDA to evaluate the efficacy and the safety of Cotara for product registration.
"We are pleased to reach this important milestone in the development of the Cotara program. Cotara now has a clear regulatory path for product approval," said Edward J. Legere, Peregrine's president and CEO. "This approved protocol provides a roadmap to product licensure for brain cancer that should make the Cotara program even more attractive to potential licensees or partners. The Company is actively seeking a strategic partner in order to further advance its Cotara program that includes the treatment of brain cancer as well as colorectal carcinoma and other solid tumor types."
http://ir.peregrineinc.com/releasedetail.cfm?releaseid=266219
So, we were there 10 years ago. Something is just not right with this picture. Could some of the board members that were following PPHM at that time explain what happened, and what is different now. Thanks.
This is from the link you provided
TUSTIN, Calif., Mar 17, 2003
" The company has received approval from the FDA to start a Cotara™ Phase III clinical trial for brain cancer.. "
That was 10 years ago. What happened to that phase III trial, did they ever run it, and if not why not? What is different this time?
Sure, I like the odds too. Look also at PPHM, it is even better.
MD1225 << he told me hes the top holder out of the 8 of us here..>>
Interesting. So, he has more than 330k shares. Oncology fellow will be lucky to make 80k per year. Where did he get the money to buy all those shares?
<<Going to fly today if we can get some volume.>>
Well, what are you waiting for - generate volume, start buying.