"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
"If it fails for some reason, what do you predict the PPS would fall to and would you still be a holder after?"
Just a wildass guess is that it would drop to $1.40 a share. The sell decision partly rests on the actual Comet data. With this size trial, statsig will require something south of HR=.85. Sutent had a .90 result, Avastim+Docetaxel had .91. If Cabo does not do at least as well as the other VEGF drugs, then it throws doubt on the whole program. If Cabo narrowly misses on the primary endpoint, then there is still room to recover with Meteor and Celestial in RCC and HCC respectively.
So I don't have a defined plan of action, I just plan to wing it based on what we see. I did not expect to be a 4 year owner of this stock and I don't want to be a 6 year owner, but it could conceivably happen.
"That was all done under last CEO Platt who should of been put in jail."
For two years Dr Traber maintained the mythology of an anticipated Colombian approval and an approved phase three for Davanat that would start imminently. It wasn't until the fibrosis story improved enough to sell the company on that basis that the less credible stories were retired.
Is Dr. Platt the only member of senior management who represents a continuity with the PRW shenanigans?
"I'm more for pervasive use of medicines but with more agent related approval metrics like ir-PFS (obviously it is hard to modify OS like this) and reimbursement based on a patient benefit metric (if he provably succumbs to AEs, there should be no charge for the medication if a drug was passed by the FDA and the company isn't hiding anything)."
So the bureaucratic overhang on medical treatment needs another layer of administrative burden?
"Patients need to understand the treatments they are receiving a little better too and a system like this would necessitate this."
Most PC patients are in their 60's, 70's and 80's. For those who want to know more, the information is available, but I suspect most in this demographic simply defer to their MD, and would prefer to do so.
"I doubt that GALT's management really intended to deceive investors."
This company actually has a long history of deceptive practices. Many of the principle participants have changed over the years, but some of the "behind the scenes" main players are still in place.
Claiming Davanat (GR-MD-01) is an excipient and as such could be approved without a pivotal trial to prove effectiveness.
Leading investors to believe Davanat would be approved in South America without a pivotal trial.
Hiring an unlicensed felon to market the securities to potential investors.
Picking and choosing from among a large body of published work to draw inappropriate and misleading favorable comparisons for Davanat efficacy.
The former CEO was found to be a less than credible witness by a federal judge.
Refusing to discuss clinical data with excuse that the FDA did not permit them to do so.
Repeatedly dropping hints that the company was in partnership discussions that never seem to materialize.
The company has a long history with paid penny stock touts and has marketed itself extensively in the Florida and Phoenix areas to reach the retirement crowd. Nothing illegal there, but look at the level of institutional ownership and ask yourself why the better informed and less gullible haven't participated in this golden opportunity.
There is more to due diligence than repeating the mantra --phase one is only for safety--phase two for dose and efficacy--phase three for approval.
Dr. Traber was brought in to dress up the company and improve its image. He has an impressive resume, but the reality is that the period of this stewardship at Baylor was fraught with controversy and his exit there was under less than favorable circumstances.
"You forgot to add, "And I've been doing this week in and week out for nearly four years..."
It's been a long haul proposition. It gets especially tense though entering a period when phase 3 results are expected. This is truly the Mother of All Binary Events. Very much a pass/fail scenario without much room for middle ground.
"not worried about phase 1 , phase 2 most studies can pass that phase, its always been phase 3 where most drugs gets rejected by FDA."
I assume we are primarily talking about NASH now. The notion of a Pass/Fail at this stage is a bit flawed. That kind of binary ending doesn't occur until there is a pivotal phase three trial with a defined primary endpoint that must achieve a statistically defined result. Until then a sponsor is pretty much free to pursue or discontinue the development of a drug up to and including a phase 3 trial. I can show you numerous studies of drugs that completed phase 3 trials that actually did more damage than benefit. From an investment perspective, it is prudent to look at all available data. To assume that phase 1 is all about safety, and use that premise to disregard the early clinical efficacy data might be a bit naive.
"Ernie you say any day."
Part of the message board conventional wisdom is that bad news is released on Friday after market close and good news is saved for Monday mornings to hit the beginning of the week news cycle. So every Friday I hold my breath and hope for no news and on Monday mornings I eagerly check for a press release. I don't really put much faith in message board mythologies, but I still can't help myself.
It's been nearly 11 months since the trial reported full enrolment and nearly 5 months since the interim analysis press release. I don't think we have much longer to wait. I still have my fingers crossed.
Actually it is a "mouse model" not a "mice model." I don't usually make an issue of poor grammar, but if you are going to quote me, please be accurate.
".... all were tested on mice." I agree. I don't take issue with the preclinical record. All drugs start somewhere and most often it is on mice. The point I'm making is that inferring that Pectin galectin inhibitors are effective cancer agents based on preclinical murine work ignores that there is a considerable body of published material on GMCT01 (Davanat) clinical trial results in humans. As monotherapy there is not a single partial response attributable to the drug and in its combination trials the response rate was equal to or less than that expect from the drug to which it was added.