Disagree. The submission gains them the 6 month first-to-file exclusion, and starts the clock running on the 30 month approval delay (ok, technically starts in a few months)
The 6 month exclusivity is only in play when the patents are NOT expired. Once the last Orange Book patent expires in 2025 it will be fair game for anybody with an approved ANDA.
The 30 month clock obviously means nothing by 2025.
So this challenge is not just getting in position for 2025 as some here say.
Do agree though that is not a big deal. Companies take gambles on these all the time. Some work, some fail. And certainly an outcome is years aways in any event.
Sounded to me like the trial would have to be sufficiently enrolled such that they would expect it to be fully enrolled, or almost such, by a decision date on the NDA. That to me implies they are already way late on launching, and will likely not see 2014 submission even if the trial opens tonight. The only thing I know of that would offset that analysis would be a trust in Raj. Yeah.
Long here, but have serious doubts about the Apaz registrational pathway anyway, The submission on the combined data has to strikes:
. It is statistically dubious to combine 2 trials that were not designed for such.
. As it now is a single trial, the "bar" at the FDA is higher than if it was still 2 trials.
And this is not baseball.
Plenty enough value in the other drugs to get this ship righted regardless of Apaziquone.
Though the primary endpoint matures in 3 weeks, the secondary endpoint of febrile neutropenia (which is a marker for infection) matures in 3 months. This is key, as it is the basis of the FDA approval for Neupogen, and presumably would be such for 2012.
So I would expect they should be able to decide within 4 months
Neupogen's P3 was about 200 patients. So would be as easy to run that trial as the P2. But there is a bit of a catch. If they need to show an improvement in infection over Neupogen, 200 patients will probably not be big enough. Neupogen was trials against placebo, 2012 will have to go against Neupogen.
The effect size seen in the P2 will be key to the trial design. If they do see a decent reduction in infection, they can just plug that into the software and out comes the trial size needed. But if the effect is minimal it gets tricky.
They might try a "non-inferiorty" trial. Or they might try using sever neutropenia as a surrogate. I would be a little skeptical of either without a SPA negotiated with the FDA, and that does take time.
I will not expect a P3 till well into 2014, but maybe I will be happily surprised.
Is not the fact that the FDA called BS on the data enough to question your belief?
Plus, your post implies you don't understand the process. They needed to run the P3 to get approved regardless of receiving BTD, break through DESIGNATION (not approval). BTD might grease the skids on the path through approval, but one still needs to run the pivitol trial.
If you miss-posted (and meant ENTA), then your comment about cure vs treatment is flat out wrong.
Both drug combos have SVR12 (what is generally considered a "cure") in the high 90% range. Each one might be slightly better than the other depending on exact subpopulation. But the difference is minor.
The real difference is GILD's combo will be less pill popping, but cost more. It it saves you $1000 out of pocket, will you pop a few extra pills for 3 months? And will insurance companies push the combo that saves them $10K or more?
If you really meant CLDX, I have no clue #$%$ you are talking about.
CytomX looks interesting (though still private).
They make "Probodies" out of existing antibodies. They attach a masking agent to the binding surfaces of the mab. This mask is cleaved off in the presence of proteases existing in the tumor environment. Thus the Probody is more selectively targeted towards the cancer.
Probably not a huge improvement, but in the coming age of biosimilars and biobetters, a modest improvement on an existing mabs could be worth serious money.
They have one in-house mab that they have made into a Probody. An anti-Jagged agent, CTX-033. They recently announced a conjugated version, so I assume that is using the IMGN conjugation technology.
On the flip side, one would assume IMGN is checking out the Probody technology on Kadcyla and the pipeline. A win with Pro-Kadcyla would be huge as it would allow a follow on deal with Roche at substantially better terms.
Looking at the neulasta label, it was approved by showing non-inferiority on sever neutropenia against the non pegalated version, but also an improvement in febrile neutropenia against placebo.
Don't know if it is possible to run a trial against placebo any more in this indication.
Short/long does not matter here. Many are "talking their books" in the media.
At least he is straightforward and admitting he is shorting it. The majority of people quoted on CNBC et all who make recommendations are doing the same, and rarely do they admit that they are simply pumping/bashing a stock for personal gain. I find that far worse.
Don't really know why people care about these anyway. They are just like the sports betting touts; if they could really tell you how to win, they would not be doing so. They are either trying to make money selling their name, or make money by convincing others to do the wrong thing. They are #$%$.
Sadly (at least here in the US), it is not even illegal for your broker to give "advice" that is intended to benefit them or their company and not you. That sucks.
BTW, Chanos become a name player when he was very vocal in question Enron's books. In the meeting before admitting massive fraud, Kevin Lay called off the Q/A and explicitly said he would not provide a forum for people such as Chanos. But anybody with a clue knew Enron was BS, so this was no big find by him.
His fund took a serious hit last year, and is presumably well down this year (have not looked).
Sorry, it would of course be neulasta.
I also think this is a very good bet.
I assume there are 3 things that are driving the PPS down:
1) The fascination with the knew immuno agents.
2) The consolidation involving partners
3) Market dislike of ATMs
Regardless, we will start getting P3 data in late this year.
The company will pay the holder of record as of the record date, friday.
But because of the 3 day settle time, anybody buying the stock on or after the ex-div date, wed, will not be the holder of record by Friday, and therefore does not get the dividend. The ex-div date is also part of the "sales contract" in that regardless of what might happen to screw up the 3 day settle, the dividend still belongs to the party who sells wed or buys tue.
Expect the PPS to drop about .50 (whatever that number is) between Tue close and Wed open (ok, this stock is so thin it jumps that much anyway, so who knows).
Looking a little deeper, this was not a cashless excise. He excised 25K worth of options and his share count went up by 25K.
My point was correct in general though, one has to watch out for that when making presumptions about what execs are thinking when they excise.
The class A was sold last Feb. on the open market, and came with a guaranteed 7% dividend (on the $25 face represented by a share of CLV). It was part of their substantial financing then.
It is completely fare. The advantage of CLV is that it is a little safer (thanks to the dividend pay, I would not even factor in BK). The disadvantage is that it does not fully participate in the upside (over about $28).
If CLF just mucks around for the next 1-1/2 years, then CLV is a better value. If IO gets hot and CLF gets back in the 30s, then CLF is the better investment.
All this has been public for over a year now. There is certainly nothing remotely illegal or unfair. It is your call which to buy (if you like the company).
Personally, I have some of both and think it matters little.
It is not a ratchet as I would define such. There is a anti-dilutive clause, but it only covers the standard items such as splits, spin-offs, stock dividends, etc. It does not have a clause that gives CLV additional shares based on Cliff selling common to the market (which to me is the hallmark of a ratchet).
As to the funky conversion formula, I don't know what you would call it. But that certainly has no aspects of a ratchet.
Just a note, it is the actual class A proper that has a variable conversion rate of 40:1 or worse. CLV is a tracking stock, and represents 1/40th of a class A share.
The way that funky formula plays out, 1 CLV will get 1 CLF at expiration if the price of CLF is under the low threshold around $28. From there into the mid 30's, the rate starts dropping so the cash value remains at $28. Then in the mid 30s the rate freezes again.
So buy paying the extra $1.50 for CLV, you get the dividends, but lose a potential gain of about $5 if things do well. Kind of like just selling a leap call as a hedge against CLF.
[These numbers are off the top of my head from the last time I did the pencil work several months ago].
Unless it was a cashless excise. In which case he sold enough shares in the transaction to cover both the excise price and the tax liability.
If so, he even ends up with a win if the stock drops to near 0, as he has put 0 in and will have a tax loss to book.
The royalty rate is a little unclear as it is both tiered, and also only on the ENTA portion of the cocktail (the latter itself is unclear). But one could be safe with a 5-6% of total ABBV sales.
Estimates for ABBV sales seam to run 3-4B/year. So we are looking at the 150-240M/y range. There are a lot of analysis who seam to be of the "GILD is God" mindset, so some may think the number will come in lower.
The kicker though is the there is also debate on how long the revenue stream will continue. To some extend there is a pool of existing customers that will drive this, and how that plays it is up for debate. And there are future gen products on the horizon (though ENTA has one also, so that can play either way).
So the present valuation might well be a risk adjusted $150M first year revenue. We lose the launch risk (slight as that is) by EOY, and have the first full Q in next winter. Hopefully all goes well, and we are sitting around $70.
First, any short can only go to 0, so the gain (on a single trade) is always limited tp 100%. People who post "Why would one short a stock at $X" just don't understand the concepts here.
Second, it will not replace local therapies (surgery and radiation), it has not been tested for such, and the concept just makes no sense. Yes, it has displaced some chemo use, but so do the new hormonals (X and Z) and they are clearly doing better at such than Provenge.
The line about "only FDA approved [cancer] vaccine" is ignorant, as there are many, and Provenge was not even close to the first. But if your info comes from a Y!MB, I guess that is what you get.
The drug has been on the market for over 4 years. It is losing a significant amount of cash and has no plans in place to correct that. And revenue is falling. Even if they eliminated R&D they are losing cash, costs more to make and sell the drug than they get for it. More competition is coming shortly.