"....why you think we have to wait."
I still think it will happen any day. Why it's taking longer? Maybe the patients are doing better than we expected. EXEL might have asked for a full package evaluating all the secondary endpoints in addition to OS. That would involve getting all the radiographic results to measure the bone response rate and a lot of subgroup analyses. Maybe something else I haven't thought of. Beats me.
"LBA deadline is 11:59pm 8/20/14...effectively, one week from Monday."
One and a half hours until it's deadline time in Madrid. I think we have longer to wait.
"Your conjecture is that pectin is totally useless. So, is LJPC doomed ?"
That is the gist of my thinking. I don't trust internally generated preclinical work. GALT has the edge in this regard with Dr. Friedman picking up the lab studies and publishing them. He is a liver KOL (key opinion leader), so his name adds credibility. Back to La Jolla, I noticed that they did a secondary a week after the press release. Developmental biotechs try to time secondary offerings to take advantage of high pps, so it looks like their press release was timed to pump up the stock price as they rolled into the secondary.
For argument sake, let's assume all the preclinical NASH work done on the pectin derivatives is credible. That still leaves the question of whether efficacy in a toxin induced animal model will translate to efficacy in a human chronic disease model. I'm frankly skeptical.
"You've been busy Earnie. Lot's of negative posts on the GALT and EXEL boards. lol"
I actually own a big chunk of EXEL. Even though I own it, I'm not reluctant to consider all aspects of the story, both good and bad.
As I was saying...The FDA lists Pectsol-C as one of "187 Fake Cancer "Cures" Consumers Should Avoid."
First you bought into Frank Salvado's bogus claims about the meaning of the fast track designation and now you are posting quackery from Teheran University as supportive to GALT's cancer program. Up your game a bit.
Okay Mitch, let's talk about PectaSol-C Modified Citrus Pectin. That is the drug being evaluated in the article you posted. That article was written by Dr.Dr. Isaac Eliaz. He also happens to be the owner of EcoNugenics, the company which makes and markets PectaSol-C. They claim their product qualifies as GRAS (generally recognized as safe) and as such, it can be sold as a food supplement. In addition to treating Ovarian Cancer, other articles and claims for effectiveness in Prostate Cancer, Breast Cancer, Fibrosis, High Blood Pressure, chronic inflammation, Colds, Flu and more. Dr. ELiaz himself says "This new research is truly exciting because Modified Citrus Pectin is turning out to be much, much, more versatile than anyone imagined."
Come on Mitch, when something sounds a bit too good to be true, maybe you should be a bit skeptical. Here is what the FDA had to say about some of the more aggressive Pectasol-C claims.
Interestingly the FDA lists Pect
"Can you provide the exact CNBC quote by pointing to the article where it appeared."
It was a CNBC report that has been archived. You can access it by searching: "CNBC's Morgan Brennan reports on the FDA's four expediting pipelines."
"Then, majority of longs bought simply because they like to company prospects and never read promotion materials."
Mitch, here is an example of how investors are duped. Frank Salvato wrote the story touting GALT's NASH drug. That story contained gross inaccuracies regarding fast track status. GALT has been aware of the story from the beginning and Rod Martin posted it on his personal website. Since the first writing, Mr. Salvato again inaccurately referenced fast track.
The following posters have referred to Mr Salvato's stories apparently unaware of the inaccurate quotes, references and inferences that some how all of this was relevant to GR-MD-02.
bigskywy cobragene 1 vvvvvvrebel89130 mitchpit11 bmpr2bmpr jgatsby1911
Like it or not, all of you guys were "duped." That's how it happens.
"Notice how AF doesn't even attempt to refute any of the facts of the article..."
Adam did exactly that, it was just a bit too subtle for you to notice. Here is what he tweeted: "By the way, you have no idea what FDA Fast Track status means."
First, Mr. Salvato is misquoting CNBC. What CNBC actually said was that 100% of the 2013 "priority review" drugs had been approved. GALT's drug does have "fast track." Fast track, Breakthrough, and Priority Review are three different and distinct FDA designations. Mr. Salvato is playing very loose and fast with the facts. So who is actually misleading who?
"Read the sentence before that one."
Mitch, here are both sentences.
"The company has received “fast track” status from the FDA. CNBC reports that no FDA fast tracked drug that has advanced to “breakthrough drug” status has failed to come to market."
Now, again the question. How is this relevant to GALT? Hint. Have any GALT drugs been advanced to "breakthrough?"
"CNBC reports that no FDA fast tracked drug that has advanced to "breakthrough drug" status has failed to come to market."
Mitch, How does the above statement apply to GALT??
"So if this were a home run how long would it take to come to fruition?"
First, there are already approved drugs to treat osteoporosis that have a better safety profile, so I just don't see it happening. But, for argument sake, let's address your question. Denosumab's (Prolia) pivotal trial was a 7800 patient placebo controlled trial measuring a variety of endpoints over a 3 year period. Now that Prolia is the standard of care, it is likely Cabo would be required to use Prolia for treatment of the control arm. To get to a phase 3 trial EXEL would need to go through the full gamet of studies to determine safety, efficacy and dose optimization in the osteoporosis indication. My guess is start to finish is a 10 year process.
"This could be a "don't bite the hand that feeds you". Exelixis spends a lot of money. Those persons benefit from that money hugely. So... those persons, even if they are the WHO IS WHO in prostate cancer research are far from being objective."
I applaud your skeptical attitude. Try to look at it from every angle and look for every possible problem with the story. Here is what I think. Whatever these guys get from EXEL is peanuts. Much more important to them is picking the next winner and staying relevant.
I will say this though. Some of these guys staked out an early position and the momentum of their initial enthusiasm is influencing the current level of support. Here's what I'm getting at. Back when the most recent data was an astounding 19/20 bone scan responses, the all-stars showed up to participate in the EXEL R&D day. Since then, not so much. Legothetis has cooled considerably. Sartor said he would not write an off-label scrip. Scher still publishes and participates, but not quite as enthusiastically as before. The Smiths, George, Hussain, Basch, et al are still pretty solidly supportive: but these guys pretty much wrote the script for the Comet protocols and once you set boundaries, you defend them. When the story of the bone scan resolution phenomenon broke, the big question was durability. The activity was obvious, but nobody really knew how long it would last. Personally, I was expecting 3-6 months and I suspect some of these lead investigators were hoping for similar numbers. The final data is obviously not in yet, but I'm thinking that instead of 3-6 months of benefit, 2-3 months might be a more realistic expectation based on the phase 2 results.
"....who are you claiming is still senior management with galt."
Come on Ace, 2 minutes with google and you can find the answer yourself.
"...and I find nothing that you claim about Dr. Traber..."
Here is what I said: "...the period of this stewardship at Baylor was fraught with controversy and his exit there was under less than favorable circumstances."
And here is a sample of the source material. "Baylor medical school spreads blame as it axes chief"
"He stayed on at Baylor until his contract ran out but in a smaller roll."
They literally paid him $4 1/2 million to stay away.
"Ernie, if it just barely fails, can they still get approval on OS? Or is it black or white? Sorry for the dumb question."
It's pretty black and white' Over the years there have been exceptions, but they are few and far between. When exceptions are made, it is because of a totality of the data. Problematic though is that so many of the recent drugs for prostate in the last couple years have shown a survival advantage so that is the current measuring stick.
"At $100mmm per year, assuming you gave up on funding further Cabo research or just sold the right to Cobi to Roche, you should have something worth in the neighborhood of $500mm."
I assume we are speculating about EXEL residual value in the wake of a Comet 1 failure. Two problems. Don't forget the long term debt on the books and don't underestimate management's ability to spend money they don't really have. They need more than just Cobi. Meteor, Celestial, RET NSCLC, DTC, MTC plus a few other cat and dog indications could conceivably get Cabo annual revenue up around $400 million.
"...if comet1 fails can cabozantinib still get approval on just pain palliation for bone mets."
Maybe, but perhaps more problematic would be getting the reimbursement agencies to pay $10k per month for pain palliation.
"Thanks Ernie, I always risk exposing ignorance when I post."
Nobody bats 1000. One of the plusses to posting is having your perceptions and conclusions tested by a jury of your peers, especially important in a sector like biotech in which the information flow can be very one-sided.
"...CoBRIM, or is it too early to hazard a guess with no more than top line data."
We don't even have topline data. All we know is that it was a statsig result on the first interim. About a year ago I figured Cobi was worth $100m per year to EXEL. That number could go up or down depending on how the treatment community perceives the matchup against GSK's Dab/Mek.
"Ernie, have you had opportunity to consider possible motivation(s) for the recent PCF pre-approval endorsement of Cabo? "Expecting" approval isn't exactly like "predicting" approval, but they certainly are leaning in that direction."
I think big dollar contributors like to think their contributions are spent to good effect. PCF looks for winners and backs them. I think they are just echoing what they are being told by the alpha members of their Scientific Advisory Board, many of whom are participating in multiple cabo trials.
While trolling through the site I found this abstract from last year. It describes some of the mechanics of Cabo resistance.
Integration of Murine and Clinical Trials links modulation of the Tumor- associated Microenvironment with Cabozantinib Efficacy in Metastatic Castrate Resistant Prostate Cancer