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Jake,
I agree. Their confidence is very high.
IMO,
Montana
heartofwolf,
The rumor I heard in June was "enrollment is ahead of schedule." Of course, how much ahead and that was 60 days ago. Shan gets an enrollment update daily.
IMO,
Montana
Volgoat and BCS,
From what I was told at the ASM; 1st look-in will be about Safety. No stoppage possible. Why? Because it will be about safety...Q2/Q3 depending on enrollment. 2nd look-in is where the trial COULD be stopped. 2nd look-in will be in 2016. When...is the question?
The new Avid expansion; It will be up and running by December.
Why? Lots of testing and permits. FDA and red-tape California.
From what I understand....The current facility is/will be for clinical testing and is for clinical testing only now. The new facility will be for marketing. Different set of rules per the FDA. The new facility will be 24/7 and will be able to make plenty/enough of Bavi and then some. (I could never get the shelf life of Bavi.)
IMO.
Regards,
Montana
Wook,
I asked SK years ago on Bavi's shelf life and he was very evasive. He wouldn't answer so I asked "Does Bavi have like 5 yr shelf life?" and he said "Yes." I hope to clarify this year.
On another note; Daniel K Ludwig...
Philanthropy
Beginning in 1971, Ludwig sold off many of his foreign interests, using the funds to endow the Ludwig Institute for Cancer Research, which he founded in Switzerland. It became his primary interest in his later years. Since his death in 1992, it has distributed over a billion dollars around the world for cancer research.[9][10]
Under the terms of his will, Ludwig Centers were established in 2006 at six United States research institutions (Johns Hopkins University, Harvard University, the Massachusetts Institute of Technology, Memorial Sloan Kettering Cancer Center, Stanford University and the University of Chicago). To date, they have received US$900 million from the Virginia and Daniel K. Ludwig Fund for Cancer Research.[11] The Centers operate independently of the Ludwig Institute. By the terms of the grant, their directors and scientists are to work collaboratively with each other and with the Institute.
http://en.wikipedia.org/wiki/Daniel_K._Ludwig
Montana
Hopefilled2014,
King said calendar Q4 of 2015. It could be October thru December. I just think Dec for my own train of thought. I wont know more until the next ASM in Oct.
On the insurance, the patients insurance is paying for Yervoy.
Imo.
Regards,
Montana
Rhyino,
He stated that at the ASM in Oct. First look-in is for safety for both parties (patients and company). The second look-in, calendar Q4 2015, could halt the trial. He noted the p-value would have to be better than 0.05. So, I asked King, the waiting game is either Dec 2015 or Dec 2016. He said..."correct."
Also, at the ASM, King said about the yervoy trial; they set it up where insurance is paying for the yervoy. PPHM isn't footing the bill. He said more trials with I/O will be set up this way.
Not sure how they did it but they did.
Regards,
Montana
MD1225,
Don't hold your breath. I believe they will hold out for a partner on the SUNRISE trial. They (mgmt) has done all the work to date and they don't want to give away their fair share. If a deal is good; then yes they will partner; until then...don't hold your breath. The look-ins I am told will be in March/April and Q4. If data is better than p-value 0.05 in late Q4 2015; then we are off to the races.
Now on the liver trial, I think we could see a partner on that front. They talked it up at the ASM. Something may be brewing but couldn't tell for sure. My guess is we see a partner for liver before SUNRISE.
IMO,
Montana
The dates to focus on are Dec 2015 and Dec 2016. I spoke to SK and he said the 2nd look in would be in Q4 of 2015. He was not holding his breath but would love to hit jackpot. He was focused on Dec 2016. He also said if Dec 2015 came back at p-value 0.05...they would probably let it continue on. P-value would have to be significant lower than 0.05 to stop the trial. He is focused on Dec 2106.
IMO
Montana
No...it is all event driven. I guess I should say they are guestimates on when the look-ins will be from management.
They will PR when enrollment is complete and that is it. No half way or ahead of enrollment PR. Just enrollment is complete.
Just said enrollment is going good and they expect it to be complete by end of 2015. King and Shan visiting they believe has helped enrollment.
IMO...
Montana
Stone and Loof,
From what I understand...
Enrollment is more like a bell curve than a hockey stick. The inflection point is now with 145 sites up and running. 160 is their goal in case some centers don't enroll. It slows down when they get over 500 patients b/c they don't want more than 600 patients so it would end the bell curve.
King and Shan are visiting some of the sites. Not all but as many as they can. Most if not all of the doctors said they have never seen management visit the center. It was encouraging. They are trying to enroll as fast and as many as possible.
There are 2 look-ins next year. The first one is in the Spring and it is to see whether the safety and efficacy is good. Basically, a Go/No Go. The 2nd look-in will be Q4 2015; that will be about stop the trial(MOS and P-value) or continue on. The trial will end around Dec 2016. All of this depends on the enrollment and how quickly patients; sadly pass. So, we are 13 or 26 months away from seeing results.
Ebola was talked about a lot. The PR yesterday was worked on/submitted back in February and now it is out. Not holding my breath; but something could be brewing for Ebola. Money is there from Gates, Zuckenberg and Gov't since it is becoming a national crisis. Need to combo like with interferon or something similar.
Liver and Breast papers are coming from the doctors...Yopp and Allison Stopeck(sp) soon. In order of importance are Lung, Breast, Liver and melanoma trials. Liver could leap frog breast if results are really good. Liver is encouraging and wouldn't be surprised to see an Asian partnership for Liver cancer. Not holding my breath but seems to be the best bet at the moment.
IMO
Montana
Stoneroad and Sunstar,
I agree. I believe the plan is
1. Get out in front of the KOL's. Someone asked Dr Brekken if PPHM management was talking to the right KOL's and he said "Yes, they are." Also, Dimtri that did the symposium in Sydney, is a/the leading expert in MDSC's per Dr KM.
2.A. Get out in front of the oncologists at Amsterdam, Sydney, Mann. Beach, and Munich and let them know about Bavi and the MOA. B. To help recruit clinics for the 150 clinic Ph III trial.
3. Get out in front of the big banks such as Webbush, Credit Suisse and Piper Jaffray.
4. Get the CA dismissed in 2013.
5. Start Ph III on their own. Possibly the melanoma trial. I believe the Ph I will start in the next 1-4 months.
With Ph III started and the pre-clinical data in hand, I believe, with a gut instinct, they will get a partnership or a loan in the first 6 months of 2014.
All imo....
Montana
md1225 and Geo - i would love to get bought out this summer but it won't happen. The company is looking for minimum $100. I am leaning toward 2015-2018. I use to think Volgoat was crazy talk but he knows or has an idea what the company wants. It won't be cheap and they will wait it out if they have to....IMO.
Wook - Bavi's 1st trial started June 2005.
Montana
I wanted to say thank you for all of the info and update on this board to everyone; especially to CJgaddy, KT, FF, WH, RRdog, FTM, Entdoc, and even ole Jazzbeerman.
I have been reading the board for years.
My friend went to the shareholder meeting last year and spoke with ES. He said the company will be sold IF Bavi works. He didn’t ask him the price but gave a price range which equaled around $5B-$15B market cap. In his opinion, he said the board isn’t going out cheap IF Bavi works.
My friend went to this year’s meeting as well. Look for a radiation trial/IST and more IST’s in 2012.
For Jake, he spoke to DP. He asked him about expanding the board with an investment banker and/or ex-BP. He said they have talked about it but right now they feel they have the best management and best support to help management. The way he talked it would be after the data comes in from all 3 of the pending trials.
RRdog/mojo/sunstar – My friend said SK was speaking at the podium and said that Dr Garnick has 17 FDA approval letters framed and hanging in his office. SK said they want to see Dr Garnick with 20 approval letters hanging in his office. My question is, what 3? Cotara, HCV, 1st line NSCLC, 2nd line NSCLC and pancreatic?
My guess is that an early buyout is not in the cards with them wanting 3 approvals and ES wanting a healthy # but who knows if Roche or Pfizer comes with a GLD type offer…?
I agree with Volgoat on HCV trial being good. HCV trial came out of nowhere with Bavi AV at the gov’t testing and no trials. Breast trails had been moving along and had pretty good data. I believe breast had some good PR and CR’s but is a crowded market and not a high unmet medical need. CJ posted a 5 yr cancer survival list and breast was the 3rd highest at 89%. FF or WH posted that Garnick said “I know how to kill a drug.” I think he hasn’t killed it but postponed b/c breast is a single/double and the four Bavi trials they are running, well……Garnick is swinging for the fences imo. I believe they saw a great/better opportunity for Bavi/Ribavirin in place of breast. The timing couldn’t be better on HCV with VRUS and INHX having great appreciation lately. I think they will run more breast trials when cash is more plentiful imo.
If memory serves me but isn’t Merck and Vertex drug’s combo’d with Interferon/Ribavirin for HCV. Wouldn’t they be interested in Bavi AV if the results are as good as interferon for replacement to maintain and/or grow their market? Just thinking if the market is going interferon free…?
I wanted to ask if anyone had a timeline on 2nd line NSCLC AA if the data is great. Mine is we see the data in June and the trial ends Oct ’12.
The company takes 4 months to put the packet info together and submits it to the FDA on Feb ’13. The FDA gives an automatic 6 month delay/answer in Aug ‘13.
My other prognostication; IF Bavi works like we think it does; the company gets bought out 2-4 years after the first approval.
FYI – My friend has no inside info or contacts other than going to the shareholder meeting in October. He also said there weren’t many people at the meeting this year.
Feel free to comment, challenge or disagree.
All in my opinion.
Have a good week and Merry Christmas.
Montana
Thank you to all for the research that you have provided.
I was reading the Wall St Journal and thought this was interesting concerning PPHM/FDA.
Bush Is Set to Nominate
Acting Chief as Head of FDA
By ANNA WILDE MATHEWS and JENNIFER CORBETT DOOREN
March 10, 2006; Page A15
WASHINGTON -- The White House is expected to nominate the acting commissioner of the Food and Drug Administration to formally head the agency.
Andrew von Eschenbach, 64 years old, is likely to be named in the next several weeks, people with knowledge of the matter say. But that could still stall over questions about whether Dr. von Eschenbach would have to give up his other job, as director of the National Cancer Institute, upon being nominated. He would likely face a tough confirmation process, tangled with controversial issues such as the Plan B emergency contraceptive and stem-cell research.
The last FDA commissioner, Lester Crawford, won confirmation only to resign last September after two months, a move likely tied to questions about his finances. Mark McClellan, the previous FDA leader, stepped down in March 2004 after about 16 months to run the Medicare program.
Dr. von Eschenbach, a urologic surgeon and cancer survivor who previously was executive vice president of the M.D. Anderson Cancer Center at the University of Texas in Houston, is identified with an aggressive goal of ending suffering and death because of cancer by 2015. Seen as an advocate of speeding approval of promising drugs, he will win support from industry but likely face opposition from lawmakers focused on drug safety, such as Iowa Republican Sen. Charles Grassley.
"He'd be a great FDA commissioner," said James Greenwood, chief executive of the Biotechnology Industry Organization. But "we've learned that it's easier to confirm a Supreme Court justice than it is an FDA commissioner."
Any FDA nominee will come under sharp pressure from both ends of the political spectrum. Democrats have attacked the agency's handling of a bid to sell the emergency contraceptive known as Plan B without a prescription, which stalled under Dr. Crawford. Republicans may want to grill Dr. von Eschenbach about the FDA's plans for condom labeling and the abortion pill mifepristone, which has been potentially tied to a handful of deaths. The agency has scheduled a scientific meeting that would address that and other infection-related issues.
A spokesman for Senator Michael Enzi, chairman of the committee that oversees the FDA, said the Wyoming Republican "continues to believe it is critical that the FDA have a Senate-confirmed leader at the agency's helm," though he said Mr. Enzi has told the White House he "believes it's essential that the Plan B issue be resolved before the Senate votes on an FDA nominee." A spokeswoman for Sen. Edward Kennedy of Massachusetts, the ranking Democrat on the committee and a fulcrum vote on any FDA nominee, said he believes the "next commissioner must have the capacity to see that FDA once again sets the standard for quality, sound science and integrity."
Aside from the highly charged reproductive-rights matters, Dr. von Eschenbach likely will face difficult questions over a range of FDA-related issues, including the possibility of copies of biotech medicines. He may also be asked about his unusual dual job at the FDA and the cancer institute, which he has headed since 2002.
Sorry Jazz/CJ, I couldn't provide the link from the Wall St Journal.