SnowFlake earlier posted a comment saying that only 41% of Drugs that were 'Fast Tracked' were eventually approved. Sorry Snowflake, I'm sure you may have been confused, but that statement is very very wrong.
The article Snowflake references starts by saying that the FDA approves about 100 drugs per year and a subset of these are considered 'Novel New Drugs'.
The article goes on to say that of the 41 'Novel Drugs' approved in 2014, 19 or 41% were designated as fast Track. The actual paragraph below. But I saw no statistic in there regarding the % of Fast Tracked drugs that get approved.
"Fast Track and Breakthrough Therapy designations are designed to speed the development of promising new drugs intended to treat serious conditions with unmet medical needs. Almost half – 19 or 46% of the 41 novel new drugs approved in 2014 — were designated as Fast Track, Breakthrough, or both."
All this is saying is that 46% of 'Novel Drugs' approved , were Fast Tracked.
Homeslice (an affectionate term i use with my friends and brothers; a derivative of 'Homey' or 'Homeboy', it means Friend. It's a term of endearment....as opposed to you calling me Whitebread which is a racial slur.. The difference between me and you.)
In any event...
You should run someones re-election campaign. Wash-rinse-repeat, That's all you do. And never answer the question you can't answer.. My question was a simple one. You said the PPS will crash because the the METEOR test will fail. Even you cannot deny that if successful the PPS will rise, and likely dramatically. The test won't fail because of their financials, the test wont fail because of poorly structured debt, the test won't fail because of the short ratio. So enlighten me. Why will the test fail? All the the things you say above may be a good reason to short the stock. I'm not disagreeing. But in the biotech world, none of that ultimately matters if you have successful Phase 3 trials. Thus far they are 2 for 3. So again, answer the question. And its OK to say, I'm only guessing
I encourage all to go to the FDA site and read up on the program. It is CRYSTAL CLEAR that the FDA really ballyhoos this program, which includes Priority Review, Breakthrough Status etc. You have to understand why. Years back they faced great criticism regarding the time it took to approve drugs as many people faced death. So these programs were initiated to "facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier" . Go to the site and they report statistic after statistic of how quickly drugs get approved once in this program. They mention how many, as I previously cited, drugs were then subsequently approved on the first review. They are so proud citing statistics on how they approve these drugs before their counterparts in Europe, etc. etc.
And counter to some here who are downplaying this event, this is not a gimmee that any company willy nilly can go get, or would do simply to pump their stock. Why? The last thing the FDA needs is to bring into the program are drugs that don't get approved, waste valuable internal resources, and worse screw with their hugely successful approval ratio. So when they grant fast track designation, they do it with that in mind, to grant fast track to drugs that have a good chance of getting approved, to then tell the world what a wonderful job they are doing approving drugs faster. Some political motivation there? Job saving? Perhaps. But the program works, and as I said earlier, go to the FDA site and they RAVE about its success. And as an example, as I previously noted in another thread, I saw reference to the program in 2012 where 9 of the 12 drugs designated Fast Track were approved after the first review. So yeah, I think this HUGE for EXEL, and anyone who says otherwise is _________ (fill in the blank) :)
Despite what my good friend semansaru attributes this decline today (company suxx), the fact is in the recent days there has been a whole bunch of noise and articles about a biotech bubble, overheated, etc.etc. I follow some 20 or more biotechs and they are ALL down today, with exception of two. Most under 2%. So maybe EXEL does suck, but that's not why its down today. It was a funny comment nonetheless. He's consistent if nothing else.
Biggest % drop in a year by almost 3X. Largest decline prior was almost 2 million, this is 7 million..As of 3/31/15. Homeslice ...what are you thinking? That force (short) is strong with you. I'm gonna start calling Luke Shortwalker..
"I just have to point you to this nugget you posted on 2/17..at the time when you posted EXEL was at 2.54
“I will not bore you with the obvious technical indications. if I were a betting man, which I am, its time to go short……… Beware! Officially short looking for a 50% retracement on either bad news or sell the news….”
UPDATE: At the moment you are short 10,000 shares, at $2.54 or $25,400. Now @ $2.90 you are down $0.36 or 14%, about $3,600. You now need a 64% ‘retracement’ to get to your original prediction."
Below, I slimmed down something posted earlier for easier reading, regarding this extension and the offering.
But, the 10th trading day after March 4th is tomorrow the 18th, so nothing has priced. From my unscientific estimate, I calculate (assuming tommorow the PPS remains where it is today), the volume weighted average of EXEL for these 10 day to be about $2.85. 120% of that is $3.42. Having said that, and assume for arguments sake that its true ($3.42), what does this mean, especially those long? I understand 15% per annum, is like using a credit card, but what does this offering do? Is it akin to dilution? Something else? Good, bad?
EXEL entered into a Note Purchase Agreement on June 2, 2010 with Deerfield. The Agreement was subsequently amended several times. The January 22, 2014 amendment provided EXEL with an option to require Deerfield to acquire $100 million principal amount of the secured convertible notes issued under the Agreement (Notes) and to extend the maturity date of the Notes to July 1, 2018, and provided that, if the extension option was exercised, the Notes bear interest on and after July 2, 2015 at a rate of 7.5% per annum to be paid in cash, quarterly in arrears, and 7.5% per annum to be added to the principal amount of the Notes on each quarterly interest payment date, for a total interest rate of 15% per annum.
On March 4, 2015, EXEL provided Deerfield notice that they elected to require Deerfield to acquire the Notes and extend the Maturity Date of the Notes issued under the Note Purchase Agreement to July 1, 2018. As a result of the exercise of the extension option, the Exercise Price of the Warrants previously issued to Deerfield will be adjusted to the lesser of (i) the Exercise Price as set forth in Section 3(c) of the Third Amendment to the Note Purchase Agreement and (ii) 120% of the Volume Weighted Average Price of EXEL for the 10 Trading Days immediately following March 4, 2015,
Not going short but have have a sht load of stop limits trying to limit further downside, not far from where it is now. I'm underwater but, unlike you and perhaps a few others, I believe there is a reasonable chance, better than reasonable chance, that METEOR will be successful. Primarily because the primary endpoint is PFS. Its hard to argue against that considering the PFS success shown in Phase 1 and 2, combined with the PFS shown in COMET. You see that right? And for that reason after being long for sometime, then go short only to see a successful test, I'll want to stick a sharp stick in my eye to relieve the pain, or maybe spend an evening with Wilder talking off label uses of Cabo, or maybe worse, reviewing technical charts with you! God please help me.
What I was attempting to do was simply gauge the likelihood of a positive Meteor readout. I have been criticized for engaging with Homeslice (Emansaru), but as I have said, he’s been right far more than the rest of us, no clearer evidence than a $2.80 (and recently $1.40) share price. AND…along with him there are 49,990,000 additional short shares. We’d be blind not to see that elephant in the room and idiots not to ask why. It would seem that Emansaru by his statement has concluded that a positive PFS is a given but the risks lies in the OS. Thanks to all for your input; Ernie, rad.doc, noggin, wilder, Emansaru, others..
"Regarding Meteor, it's the OS and not the PFS where the risk lies (despite PFS being the primary endpoint). The acceptable PFS is already baked in."
What I learned:
The Meteor trial, approval is primarily dependent on PFS. The secondary end point of OS is important from the standpoint of non-inferiority (no negative effect on survival), but a definite level of stat sig OS is not required from an approval basis.
The METEOR OS data will take much longer to mature, and will not be vital to gaining approval in a VEGF-refractory setting. Existing TKI therapeutics in mRCC have all gained approval based upon PFS, which is an approvable endpoint in this indication.
To put this in perspective, Comet I could have been approved if mCRPC only required a primary end point of PFS, since it showed stat sig PFS, and non-inferior OS
"Secondary endpoints for METEOR include overall survival and objective response rate. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm." The secondary endpoints may not even be even fully calculated (enrollment was only completed 6/14)
There are many more drugs approved for hormone-refractory metastatic prostate cancer that have demonstrated OS benefit than there are for metastatic renal cell cancer. Any new drugs are welcome in the RCC arena and PFS is a
I'm long (very) so like others here I am hoping for that spectacular rally and/or buy out. But how lame is this management? Go to the website, click on Clinical Trials tab, and read the second paragraph.
"We are also continuing to follow patients enrolled in COMET-2, our phase 3 trial of cabozantinib in metastatic castration-resistant prostate cancer (CRPC), and we anticipate data from that study before the end of 2014...."
Its one month into 2015, they already reported this failure 8 weeks ago. Why on God's green earth is this statement on their website? Can you possibly be more lame? I'm begging you EXEL, hire a high school sophomore, have him/her delete this paragraph..Or for that matter hire a high school sophomore have him/her run your company.
I'm begging you guys..BEGGING, and I'll bet the rest of us here are too, to just STOP it. You two, 3, 4 just bring down the entire board with worthless drivel, and person attacks. Why you both take such glee when each other loses money is beyond me. This board was so civil until the stock started to move. then pow, right back to the kindergarten playground. Wilder I value your contribution more than most, but please don't get sucked in again. Hairy.. you were right for so long, and God forbid you might have to eat a little humble pie as some poor souls may recoup some of their kids lost tuition money. Does anyone else agree?
You know I could not agree with you more. Wilder, these unprovoked comments are not you. You are better than that. What happened to that Easter love you showed us?
There are many more drugs approved for hormone-refractory metastatic prostate cancer that have demonstrated OS benefit than there are for metastatic renal cell cancer. Any new drugs are welcome in the RCC arena and PFS is an acceptable endpoint.
The 25 patient ph 1 trial in RCC is the only reference material we have for Cabo efficacy in RCC. It had medians of OS 15 mos and PFS 13 mos. More telling was the 28% ORR. A small sample size can inadvertently have a high number of participants with indolent disease that can skew PFS, but response rates are a more reliable statistic. Affinitor's historic ORR is negligible and its PFS was 5 mos and OS 14 mos
In conclusion, as maybe Bill Clinton would say, “It’s the PFS stupid”. The OS is not the risk, it may not even be fully calculated, to impact the study. And Cabo has already shown positive PFS stat sig results in several other studies. And finally, the phase 1 in Meteor showed a PFS of 8 months greater than the bar we need to hurdle, Affinitor, and 1 month better median OS, and a 28% ORR improvement.
So, with all due respect to my friend Homeslice, and anyone else who is short, if you are short because you are betting on a bad OS readout, you’d be making a very foolish bet, IMO…especially if you have already concluded like everyone else that the PFS will meet the endpoint.
Yet one other nugget.. I'm trying to determine if their are any statistics on % of Fast Tracked drugs that eventually get approved. The FDA site has a lot of information on Fast Track, Priority Review, etc. Its very clear they pat their themselves on the back regarding how quickly and how many drugs get approved once they attain these designations. What I ddin't see was ANY mention of drugs that did not get approved once designated or statistics on this. Not saying they aren't there, I just didn't see them. However, I did read from a 2012 article or bulletin from the FDA on these programs:
In 2012...."Of the 12 drugs that received a Fast Track designation, 9 (75%) were approved in the first review cycle"
I don't know what happened to the other 25% that weren't approved on the first cycle, but I would not be surprised to learn that most are all were eventually approved. Even if they were not...I like our odds!
and one more nugget from that article that I think bodes well for this designation..
..In 2014, CDER (FDA’s Center for Drug Evaluation and Research) acted on or before the PDUFA goal date for 40 (98%) of the 41 novel new drugs approved..... AND
CDER approved more than three-quarters — 32 (78%) — of the 41 novel new drugs on the “first cycle” of review, meaning without requests for additional information that would delay approval and lead to another cycle of review.
All good, no?
You have answered a question I previously asked of Ernie or someone. That though the drug may be targeted at an unmet need, or whatever the criteria, why would the FDA grant fast track status, if previous data (phase 1 and 2 for example), wasn't in some way compelling? But having said that, it doesn't mean they eventually get approved (sounds like 50% don't), but its at least some validation from the FDA where before there was none. I guess in some ways it would be more compelling 'news' if it wasn't granted fast track. So we got that going for us. Anybody agree?
"Seems to me we can expect the data to be very good, why would FDA grant the fast track just before public release of the data ? Would the FDA grant fast track without seeing the data already?!"
i'd love to believe that, and at some level it would seem to make sense. Why Fast Track something that has a high likelihood of failure and waste all those FDA resources reviewing it. But aren't all these tests doubleblinded or whatever? Does anyone really know (including EXEL) the results until the test is completed?
How have you been?
Your track record not withstanding, you just can't say 'the test are going to be a failure' without an explanation. Don't tell me some know without telling how they know, and more importantly how you know they know..What does 'they know mean"?...if you are saying the test will fail, it has to be based in science, it's chemistry, it's biological underpinnings. You say the Kool-Aid drinkers are 'ignoring the facts'. Ok what are the facts with regard to this test? Now, it is my opinion, you are not only speculating on a bet, but you want it to fail mostly because you hate all these kool-aid drinkers.. You want it to fail, so you can throw it in their faces. Your short bet is just that a bet, and if you are only betting on the outcome of Meteor, and not offering an explanation of why the science will fail, then its you that's ignoring the facts, or better said, don't know the facts. Having said that, there's nothing wrong with that, but lets call what it is..
Now here are some facts. EXEL is 2 for 3 right now. Success with CABO for medulary cancer and Cobi for melanoma, but failed with CABO for CRPRC. But if the end point for CPRPC was PFS and not OS and the patient pool not nearly as sick, (see meteor test structure) there's a good correlating argument to say it would have 'succeeded' .. So why didn't they do that? No market for that . But Meteor is different, and has already shown success in Phase 1 and 2 (and actually in phase 2 for CPRC). Add that to the CABO success with Medulary Cancer and it wouldn't be a stretch to say you're laying a lot of points with your bet.. But again, that's all you have is a bet, based on no facts...at least that you have shared with us.
Of all the people on this board it is me more than most who point out your record, that, contrary to what you actually said about yourself above, you seem to be more right than wrong. And more than others I encourage 'constructive ' dialogue. (doesn't mean we always agree), far more than anyone else. I address you in a friendly way. You object to that, but worse, for some reason you think its ok to sling a racial slur at me because i call you 'friend'. That speaks volumes of you..not me. I'd like to think everyone has a redeeming quality, but racial slurs? Maybe you are the exception. Are you? But I'll thank you for finally answering my question.t. The fact is you cannot, or haven't anyway, provide any argument regarding the science of the results, and as you said its just a bet.