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Then again maybe DD & AF just enjoy playing Wack-a-Mole and it gives them something to pontificate about.
This news is a bit premature for Peregrine but once Bavi is approved for one application this strongly comes into play:
From todays NYTimes "Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses"
http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?nl=todaysheadlines&emc=edit_th_20121204&_r=0
Who me tease...
Seriously, if bavi continues to show doubling of survival from the SOC in the concurrent Phase II and IST trials and if the Phase II second line data problem can be favorably resolved, it would be unethical to subject a large number of patients to the SOC + placebo in a Phase III demonstration. The new breakthrough pathway to approval is designed for just such instances.
Is the conventional Phase III pathway appropriate for a potentially revolutionary drug like Bavi?
Once again I recommend viewing this week's BioCentury webcast:
http://www.biocenturytv.com/player/2000894425001/2003420183001
. The new FDA Breakthrough Pathway seems taylor made for a drug like Bavi. And for the irrationally exuberant please note that the first such drug has been approved but not yet announced.
After watching BioCentury This Week broadcast this morning (http://www.biocenturytv.com) on the new FDA breakthrough pathway to drug approval I wonder if a doubling in MOS in the most aggressive cancers would qualify?
Any thoughts...???
Hey I'm happy the way it worked out. I had a long term 5000 @ 2.50 buy order expecting a bear raid. Fortunately I saw the news and had just enough time to cancel it before the open.
I regularly give presentations, some contributed some invited, at international scientific conferences (never at a plenary session) and expect that in the five minutes question time after the talk i will get hard queries from the audience. The fact that Gerber presented the KM curve with ticks and all to that audience in plenary session speaks volumes for his confidence in the data. Now admittedly there were some problems discovered later with coding but the ticks were there in the viewgraph and I'm sure his peers were aware of their meaning and noted their distribution. I do not know if questions were posed at the time, but he must have had confidence that he could successfully parry with the skeptics.
Well if you want to entertain paranoia regarding test evaluations. I recall (possibly fallaciously) that the PFS of the first line study was apparently anomalous. The blinded independent evaluation found that the placebo arm PFS was more than one sigma longer than the historically expected value for first line lung cancer. Possibly two standard deviations and clearly an outlier. While the Bavi PFS was only slightly longer than the placebo. The individual investigator numbers were in line with expectations for the placebo arm. It appeared to me at the time that possibly the scans submitted to the independent review had been randomized, blending the placebo and Bavi arm data. Could the encoding have been tampered with or a gross oversight have occurred ?
If this is so this should not effect MOS. So I am still hopeful.
It looks like that I will be working in the area the week of the ASM.
I may take off that day off to attend.
Who's handing out the torches and pitchforks?
"If you eliminate half of the people who died early from the study"
Why do you believe that half of the people who died early were eliminated from the study?
One can not infer this from the censoring data.
That's why the Chicago data were clearly labeled "interim" results.
I don't believe a private board is necessary. The traffic here should die down in a few months. I appreciate intelligent contrarian options and do not want to see them excluded.
On the other hand even months ago I could never get through much less stay current with the discussion on this board. Don't you guys have a full time day jobs? I hold off contributing assuming that someone in the pile of unread posts has made my point and had the time to make it more persuasively than i could.
Well FTM if you are right then the combined statistics of the two treatment arms are still valid and statistically significant.
Well it might be informative if someone who lives in the neighborhood would go by and check the number of cars in the parking lot evenings and weekends and report back.
Just wondering:
Since Bavi principally works by juicing up the immune response, alerting it to the presence of a tumor(s), would it work better (faster?) if an immune adjuvant such as ribovarin were also employed in the treatment?
(I know that finding out would probably entail a whole new run of preclinical - phase I - III trials.)
Just wondering?
Hey TekNuLoof are you growing any of this potent anti-angiogenic compound in them thar bushes?
How about a new trial of Bavi and ....
http://www.thedailybeast.com/articles/2012/09/06/marijuana-fights-cancer-and-helps-manage-side-effects-researchers-find.html
The time delay in contacting patients who have left the trial also explains SK's previous comment that one cannot linearly infer the MOS by counting the days/weeks since the last update.
That might be sweet revenge but its not professional. I want Steve to use his every minute to lay out the Peregrine story. Then, in the Q&A, if a convenient opening arrises he can blast his and PPHM's critics.
The SEC has much bigger fish to fry and are under staffed and under funded.
CP you are putting too much weight on certainly -> certain. What was certain then that there was a very real possibility that the MOS may not be reached by 7 Sept. I would generously interpret this as meaning that there was then a high to moderate probability that this might happen.
Only $10 million. If AA permits say $200 million with 50% profit and phase III costs millions, how will a 10 million fine persuade a pharma, especially a BP, to be more diligent in completing their p III study?
In the unlikely case that the pps is >= $15.625 I will be attending the ASM assuming also that I don't have to wear a tie. (64000 shares).
Nope. $200/share min.
Hey, if the Chicago conference Sept 7 is anything like the physics conferences I attend, I would not expect a webcast or any information other than the April abstract to appear before the presentation. I just hope that Peregrine puts up Gerber's slides and perhaps a PR soon after the talk. You guys shouldn't expect instant gratification unless you are willing to show up in Chicago and pay a whopping conference fee for a ten minute talk in an overcrowded conference ball room. I would not expect the slides to reflect answers to questions or any interpolated remarks in the oral presentation. Just don't get worked up in a tizzy at the time of the talk pounding your computer.
Hummm... Sort of like Sigfried and Bruenhilda. I hope PPHM leads us all to Valhalla rather than experience a Gotterdammerung.
An interesting article on cancer stem cells appearing in Nature
http://www.nature.com/news/cancer-stem-cells-tracked-1.11087?WT.ec_id=NEWS-20120807
It was my impression that SK publicly committed himself to promptly report when the MOS had been reached in either of the Bavi arms during either/or the JMP brief or the cc Q&A session. " Promptly" is open to interpretation of course.
Using PG 650 imaging to follow up any CRs in the present trial(s) would be interesting but at this point it would be unlikely to convince anyone (present company excepted) without some general acceptance of its accuracy. Imaging trials are under way but how long will it be before the results are published. And after that known to oncologists in general.
I personally would happily forgo some of the speculated extreme price appreciation of this stock if bavi can be made widely available at an affordable price for many indications.
How many million do I need?
(Finally in the black & 60k shares.)
I hate to be crass but Leishmaniasis mainly affects the 3rd world poor and people in developing countries. I assume that the bavi used in the Leishmaniasis treatment is the same bavi employed in our cancer trials. How does this effect the future price if approved for all indications. Would India attempt to produce a cheap knock-off if the Peregrine's bavi is not affordable for its population? Comments?....
1. $2 98.3%
2. $5 82.6%
3. $10 58.2%
4. $20 6.2831853071795864769%
CJgaddy the GEM percentages in the ECOG row do not add up to 100%. Missing 6%. ???
Well 124I-PGN650 immaging would be useful in clinic however if another pharma were to use it to access the effectiveness of a new drug application in clinical trials it could bias the results since PGN650 may well have anti-cancer properties immune enhancement properties itself.
This morning the CLDX board was excited about a new guidance from the FDA concerning AA in BC.
Requirement a well conducted test showing CR. CLDX has never shown CR in BC, we have 24% in second line. Any comments medicos?
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf
It would make sense even without anything new to announce just to raise awareness of the co to the medical research community. Don't get your hopes up for a breakthrough announcement. IMO
Hey, Kiev isn't in Russia. Its the capitol of the Ukraine.
http://en.wikipedia.org/wiki/Kiev
Ukrainians who are not ethnic Russians would not like to think that people still believe that it is in Russia.
Being mildly paranoid, I would suspect that the scans were shuffled before being sent to the independent evaluators.
I doubt that the 24/7 work schedule at avid necessarily implies a vastly increased production. It is unlikely that they can cook up a batch of bavi, cotera or a contract product in an 8 hour day. I would expect weeks or more of constant 24/7 processing per batch including prep, testing and clean up.
Why the predominance of weird fractions of a penny trades today?
Hey Dew.
Speaking about peer review, what is your opinion of Dr. Thorpe's research.
Do you believe that it is insignificant or faulty?
Do you believe that Thorpe and UTSW are being naive in trusting the commercialization of their research to Peregrine?
Or do you think that Thorpe is a knowing participant in the "scam"?
"I would like to know why Dew and friends even care about a little old Biotech named Peregrine"
My guess would be the ego gratification from playing pharma Whack-a-Mole.