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Let me be the one to say it. I thought the call was not good.
I hope the partnership comes through as advertised but I remember the government contract ... I got a bad feeling today...
Hoping it was just me, but they didn't seem to be up on the arm imbalance issues at all. They really should have been. Maybe it turns out to be a non issue, but they should have known, IMO. Instead, it sounded like they were caught flat footed ... how can that be if they've been doing intense due diligence with potential partners for ... weeks, if not months?
Love you guys. Want like crazy for this stock to live up to all of our lofty aspirations for it. I'm not nearly as confident as I was just a few hours ago.
Would be sweet if they put no news in the press release, the shorts got sucked it and then crushed by an announcement during the CC...
Would be sweet...
I guess the new plan is to release at 9:29.59 ... I haven't felt this desperate since I was a teenager in heat...
http://www.silobreaker.com/adding-bavituximab-to-secondline-chemo-for-latestage-nsclc-doubles-response-rate-5_2265960913565646924
Lots of PPHM and NSCLC centric links to articles.
Sorry to be so long with this reply. My brain must have stopped working there for a while.
A note on Genentech. This is quick, largely from memory, then I'm going back to bed...!
Genentech patented a method to fold proteins using ecoli. It was used in making growth hormones. They licensed the technique to a company, Tercica, that made Increlex, FDA approved as a twice daily shot for children with short stature.
Another company, Insmed, developed another compound that looked to be as good or better than T's and that only required children to take one shot a day - IGFBP-3, or Iplex. To manufacture it they needed Genentech's patented protein folding method.
They approached Genentech, Genentech said no. I believe they had granted an exclusive license to T.
Insmed decided to try manufacture anyway and to challenge Genentech's patent based on prior use. They lost. No accommodation could be found that would allow those children to only have to take one shot a day. You should have seen what the mothers of those children were writing. It would have broken your heart.
Genentech allowed Insmed to do a PII trial with Iplex for MMD with the possibility of a three-way partnership deal if the trial succeeded. The trial failed.
Insmed stopped manufacturing Iplex and it's no longer available. Which was a blow not only to children with short stature who had to take that second shot every day, it was also a blow to the ALS community (Lou Gehrig's Disease), because they had been granted compassionate use of Iplex by the FDA. Genentech allowed Insmed to continue to sell Iplex to ALS patients until the supply ran out two years later.
In the business world of biotech, it's not always about what's best for the patients or the better technology. Genentech/Roche is an awesome company but they are a business. Considering the conflicts of interest, I'm not sure they'd be our best partner.
are you saying 8 per arm or 4 per arm? or what?
UPDATE:
The difference is that they would have to share the revenue with Peregrine. If 50/50, (i.e. Elan/Biogen Idec) the question becomes, where do they make more, half of bav or all of bev? Biogen Idec ramped the sales of Tysabri slowly until Avonex went off patent. There were other issues, but there is little doubt that that was a big part of their strategy. Avonex first, then, if the MS isn't responding, try Tysabri.
I don't believe Sanofi has an oncology portfolio that competes with bavituximab as directly as Roche's portfolio. And they have Taxotere which is known to complement bavi and is already approved in 5 different cancers.
Just shooting from the hip. And I would love to be partnered with Roche if the conflict didn't cause problems. Maybe that's why Peregrine wants to retain marketing rights in the USA, to prevent that kind of conflict of interest hurting bavi sales.
I'd go with Sanofi over Roche. Roche could delay the development of bavi. I'ts been done before. Roche already owns a large chunk of the oncology market. Their benefit from bavi coming to the market is diminished by the fact that they would be cutting into their own business. But Sanofi would be enlarging it's market share in all areas. And as you pointed out, they already have an incredible distribution channel for their taxane.
Not sure. Online is more hungry for content, needs more as a rule. But this increase in share value is getting a lot of eyes. 1000% increase in three months.
We made the Wall Street Journal.
http://online.wsj.com/article/BT-CO-20120907-710614.html
Tell it to my wife.
I love our dirty-dozens rag-tag message board. What a great testament to the power of people when they work together to accomplish something good. For me, it's been a 3 year ride. .39 was painful, but 4.39, not so much... :o)
Chicago reports no imbalances between arms. If balanced, historical data not relevant. 90% of all patients were stage IV. All others were stage III.
MOS data not final. Majority of treatment arm patients still alive.
Lots of data coming out today, though. Trial legit? TBD
Ignore the stock price. This is going up. Hold and buy if you can. Margin is dangerous to your financial health - especially in biotech.
Releasing the numbers ensure the presentation will be well attended. People are going to want to know more.
The key is that it is stat. sig. now. That means ... ?!
It's one of the reasons I don't use stop loss orders. I know a lot of DNDNers who had their shares taken away in those 75 seconds. The price shot back up and there was nothing they could do to get their shares back. They screamed. They called in the SEC. The SEC said, "Nothing wrong here..." They lost a lot of profit.
Your stop-loss order is somebody else's lay-away order. If the stock continues to rise, they'll be by to pick up their shares (were yours) presently.
I suggest you don't use margin and don't use stop-loss orders so you can ride out any storm. It will get uglier than it's already been.
I was thinking one could develop a vaccine...
A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.
inject bavi-coated/ps-coated/weakened or killed cancer and/or virus cells and ... ?!
Somebody should write an article entitled, Closing Pandora's Box - Bavituximab's Fab MOA
Actually, I don't know enough to know what's possible...
Doesn't the MOA depend on educating the immune system by masking the PS signal? No PS and bavi just clears the system...
I'm no expert in this area, though.
Read the abstract. You know what's coming tomorrow and probably all the way through into late next spring.
IMO
No treatment without side effects. Will want to get the best balance, efficacy and AEs.
Hadn't thought about it, makes a lot of sense. Will be fun to watch if they've done something with all the major players.
Leslie Mulkey ?@ThurlyThister
Peregrine Pharmaceuticals (PPHM): Survival Graphic based on Chicago Abstract. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79291692
5:01 PM - 6 Sep 12 · Details
That would put us at 12.4 months MOS and counting. That would put us at 129.63% improvement in survival. And counting...
Just noticed that we can tweet and Facebook any of the messages we see on IHUB. I just Posted MJ's graph on Twitter.
IIRC from FTM's tables (or an article, I can't remember right now), they were not sicker. Ours are 90% Stage iV, 10% Stage III. I'm pretty sure the other trials actually had healthier patients. I'll double check when I have time.
He stated in the abstract that there were no significant differences between arms of the study. If the control arm was sicker than they were in the historical data, so were the treatment arms.
What will matter to the FDA, given all arms are equal, is the relative differences between the arms of this study.
The trial only controlled the variables of this trial, not all past clinical trials.
This is going to be a ramble...
FTM, I thought they said the trial unblinded at the start of May.
The control group had already evented MOS and were at the time of unblinding at 61% evented.
Mojojo speculated that they evented (51%) in late February.
The treatment groups at the beginning of May (not late February) were at 35%. It's impossible for us to know where the treatment arms were MOS wise when the control group evented.
At the May unblinding (about 2.5 months after the control arm evented) there was a 35%-61% difference between the groups.
That means, at the time of the unblinding, about 14 members of each separate treatment cohort had evented death. We've been waiting for 7 more members of both treatment arm cohorts to event to get to final MOS.
Neither treatment arm has evented MOS as of the time the Abstract was written.
Early May to Early September is 4 more months.
Fewer than seven people have died since the May unblinding.
Without doing the specific calculation/guestimation, it looks to me, on the fly, like the rate of eventing has declined significantly.
Could be that immune thang kicking' in.
Especially since, according to the abstract:
Of the 121 patients randomized, no significant differences were seen in baseline characteristics (gender, age, ethnicity, ECOG or disease stage.)
So although the control arm enrolled very sick patients, so did the treatment arms.
I agree.
His 7-8 MOS should be low - I have it around 12-13 months currently. But yesterday's fudge didn't comfort me much. Hoping we're correct in thinking SK didn't want to steal the thunder of the Chicago presentation.
Still, it's all possible until it isn't.
AF at least understands the story -- the potential -- now. Before Stifel, I don't think he did.
I'd look at the Advanced and Metastatic Breast Cancer trial to see if there was any indication on how long it took them to determine they had complete response in that trial. They may not have reported that data.
The trial did ultimately report that they had a 10.9% CR rate in that trial.
Sorry I can't do it now, I'm working.
I don't think we can count on CRs being reported tomorrow.
In the study posted by FTM, IIRC, patients were classified as CRs around 14-18 months into that immune modulatory study.
The treatment in that study wasn't Bavi, but we should be aware that CR data may not yet be mature for either of the 1st or 2nd-line trials.
Articles like these make me glad we have our bird in hand. It's a long way to Tipperary.
Meanwhile, back in Tustin, a dramatic prolongation of life and, perchance, cancer immunity. I'm on the side of the CR+5%ers.
TBD
I transcribed the section myself. (I missed it originally because of a delightful, 3-year old domestic distraction.)
14:00
Next step, this Friday Chicago
In that presentation we’re planning on giving an update on OS in the study, we’ll have more info on patient profile, the statistical analysis in the trial so far based on interim analysis, as well as how the data is trending from a subset analysis. For us that will be a big event and one that we think will really make it clear why we’re so excited about this drug and why really a tremendous amount of partnering interest has been driven by the data we have presented…
I think they know where they are on survival. They're holding it for Chicago which is only two days away.
Baby interrupt. What did he say about Chicago?
As of recently have not reached events for median overall survival data...
No clear if he's referring to July or a more recent review of the survival data.