i don't think the dose reduction is as big as people think. the design dose in the early stage RCC trail was 140 mg. however, dose reduction was common such that the median dose actually used was 75 mg. So, as a result of "extensive dose work across multiple indications", 60 mg was selected. also note 60 mg was used in the mCRPC trail and it basically duplicated the results seen in the earlier stage trail designed to used 100 mg. So, considering the cabo dose in meteor is only slightly less than the 75 mg used in the previous RCC trail, we can only trust the company is correct in it's choice of 60 mg.
I like our chances of success in RCC but i can't really wrap my head around it definitively enough to give it any odds. I can only say that i strongly believe it's much more likely to succeed than not based on two facts: 1) the earlier data in RCC and HCC were much better than what was seen in competing drug trails. 2) cabo as been very consistent in it's efficacy across multiple trials of different size and indications. i think it's very likely the earlier cabo results will be repeated in RCC. The question is will the control behave as expected and there's enough data to believe that it will.
the issue with the comet trials was they didn't have a clear understanding of what the benefits were for the control arm and to add insult to injury, they underestimated those benefits. The treatment arm for both comet trials did show some benefits; however, the benefits shown where not better than what was already achieve using the standard of care. The design of the comet trails had no margin for error; it was obvious they were swinging in the dark and hoping for a home run.
Unlike in mCRPC, the design for both RCC and HCC has a huge margin for error when you consider the threshold need for success for both the METEOR and CELESTIAL trails are significantly less than the results seen in the earlier clinical trials.
Also, data for cabo to date has been very consistent across multiple trials. Even for the failed comet trials, the treatment arms performed similar to those from the earlier trials. what doomed exel were that there were no control arms in their earlier mCRPC studies to show them that cabo only had limited efficacy in mCRPC and was not worth chasing. in fact, even without the control data, exel shouldn't have chased after mCRPC b/c there just wasn't enough data to design a good phase 3 trail but the company was too greedy to see clearly.
mj, you could be right, but since he has stated his position, real or not, he's gone on record and we can see how good a trader he is or not.
seman, i take what i say back, you're not gutless, though depending on how this pans out, you could still be a fool. got no problem with anyone talking their position since that's the game we all choose to play. i see your 10,000 short shares and raise you 300,000 long share. on top of that, i don't intend to sell any shares until meteor results are out. do you have the same conviction to be short going into the meteor result?
seman, you really are a fool... by investing aren't we all betting on the stocks outcome. if you want to bet the stock will go to sub 1 by 1/1/15, then just short or buy puts or sell calls. there's all these ways you can bet against us longs but here you are making this cowardly excuse to not place your money where you mouth is. stop making this stupid childish wager knowing that it will just get ignored; stop being so damn cowardly and just short exel until it hurts if you've got any balls. otherwise, you're just another fool trying to talk big but fooling no one.
the 8mm/qtr cash burn includes the cost of running the cupid 2 trial. so far, the company has been very conservative in the size and number of the trials they are running. now, if the fda requires them to run a large phase 3 trail after successful cupid 2 results, than no doubt the qtr burn rate will increase.
if you look at the cupid 1/2 trail, you will see that "MYDICAR is Administered on Top of Optimized Drug and Device Therapies" so, it will not replace pacemakers/ICDs anytime soon.
I've seen reports saying there are 400,000 devices install yearly in the US. cost for ICD is around 26k and pacemakers are around 7k. that's only for the device. the cost to implement the device adds another 10k to the bill.
as for the cost of MYDICAR, the company has not come out with a price yet b/c that would be like putting the cart ahead of the horse. however, they have mention 20k as an example when trying to size the market b/c that's usually how much it costs to treat a heart failure.
akanz2, 135mm? the company's burn is roughly 8MM/year and as of last qtr they had over 90MM. So, the company is currently well of financially. Now, if CUPID 2 is successful and is approved in the EU (not sure where the FDA stands with regards to cupid 2); i doubt any of us will be mad with them for raising capital to support the launch of MYDICAR.
ulingt, it's best to just ignore socialidiocies since nothing he says makes any sense. how can cabo be designed to "fixed Gefitinibs failure", when they don't even have the same target? another thing socialidiocies does is treat theories (pulled out of thin air) as accepted fact. you will note that his theories do not reflect what has been observed in clinical trials. e.g. he thinks RCC will fail but does not and can not explain why we saw such strong phase 1 cabo data in RCC. Here's what we have seen from the cabo RCC trail:
"Tumor Regression. Objective evidence of tumor regression was observed in 19 of 21 patients (90%) with ≥1 post-baseline assessment. Best overall response was determined per RECIST criteria with 7 of 25 patients (28%) showing a confirmed partial response (PR). Importantly, PRs were observed in heavily pretreated patients, including 3 patients with 2-4 prior systemic therapies, and 2 patients with 4 prior systemic therapies. Thirteen additional patients (52%) had stable disease (SD) as their best response, and only a single patient (4%) demonstrated evidence of primary refractoriness to cabozantinib with a best overall response of progressive disease. The rate of disease control (PR + SD) at week 16 for all 25 patients is 72%.
Progression-Free Survival, Overall Survival, and Treatment Duration. Kaplan Meier estimate of median progression-free survival (PFS) is 14.7 months (95% CI, lower limit 7.3 months – upper limit not reached). Median overall survival (OS) has not yet been reached after median follow-up of 14.7 months. The estimated 1-year survival rate is 60%. Seven patients remain on study and progression free with treatment durations ranging up to 21.8+ months."
Anyone can dream up theories... but only fools will continue to argue against empirical data. with socialidiocies, we have such a person. But it's your dollar so believe who you want.
the same kink of company that loaned them 400 mm without them having any proven source of revenue.
seman, so scary... exel in a stranglehold? what's next, deerfield is going to do a dropkick on exel or will it be a DDT? give me a break, cabo just needs to succeed on METEOR and your stranglehold will turn into a neck massage given by deerfield or any other other financial firms of their choosing. who's afraid of the seman, the boogie man.
drummer, who are you trying to scare? mom and pop investors? Roche passing all the cost to exel? we don't know what kind of revenue will be generated from cobi? debt that is not refinancable? debt will be converted to equity to wipe out equity? do you think exel longs were born yesterday?
why don't you name one company with a profit sharing partnership that didn't record any revenue from the first year of sales? don't bother to look, you won't find any.
if we want to know what sort of revenue potential exist for cobi, you just need to look at existing sales for vemurafenib and you can expect cobi to quickly match these numbers. Zelboraf sales in 2013 was 400 mil with 138 million in U.S. sales. exel has double-digit royalties on sales outside the us. so, cobi should quickly ramp up to generate revenue of 75 to 100 mil for exel.
who says the debt isn't refinanceable? are we to believe that the company can't issue new debt to pay off the existing debt just because you say so? companies roll the debt all the time and exel won't have any problems doing it either if METEOR is positive.
Also with a positive METEOR, the company will be able to do another secondary at a good price to keep the company rolling.
By investing in EXEL now you're betting on positive METEOR results and that cobi can limit losses if cabo flops. if cobi was to be sold, it could easily sale for anywhere btw 500 million to 1 billion based on sales multiple on early revenue projections for exel between 75 and 100. since cobi should be effective in other future indications and assuming current potential revenues of 100MM, it's not unreasonable to expect a buyer to pay a multiple of around 10 or 1 billion for cobi on the high end.
drummer, you're not scaring anyone.
would not surprise me if seman works for either deerfield or goldman. it's a shame yahoo does not provide the ip address for posters. good way to find out if bashers are some no name day trader or wall street #$%$.
wow, looks like EBC-46 is the holy grail of cancer treatment. checkmate, all the existing cancer drugs are doomed. i can see it now, the FDA is going to approve it this year without any clinical trail b/c it's just that amazing. great opportunity to short the whole sector since this will put the squeeze on all companies with existing cancer treatments. you're the man seman!
urabt, don't hold your breath, exel's management is not as dumb as you to give a way the cow when it's so close to giving milk. you should go back to index investing where you belong. biotech investing is no place for cowards.
answer me this, how do you think the company has been able to survive all this years without any revenue? how do you think they were able to raise money to fund their research all this past years b/f they even had an approved drug? since the company has been living from paycheck to paycheck, haven't they been living from one liquidity crisis to another based on your narrow views. so, now that they have an approved drug and another that's going to be approved, you suddenly think that they won't be able to raise any funds to continue their operations?
truth is, you're a coward who bought into mCRCP being a slam dunk. now that you've been slapped in the face by reality, you're afraid to sit through another binary event so you're running around like a chicken with it's head cut off screaming "why isn't the company doing anything to raise the short term price of the stock so I can get out at a higher prices" b/c you don't have the balls to wait for the METEOR results.
the truth hurts huh?
bla bla bla, why don't you go crawl into a corner to cry about your losses. boo hoo hoo, why isn't the company liquidating their assets so i can recover some of my huge loss.. you're the type of investors that always finds himself holding the short end of the stick and wonders why. chump.
didn't i tell you already that your failure stems from you thinking you can value a biotech based on fundamental analysis? so, go ahead and stick you head in the financial reports but don't be surprised when the company does not behave like you think it should based on your reading of the financials. and it doesn't take a person with a degree in accounting to realize that a company with debt needs to raise money. it also doesn't take an accountant to tell you that there's nothing in the financials that's going to tell you how a company will meet it's obligations... but don't worry... this is where experience comes in... and it seems like you have none what so ever when it comes to investing in these sort of company. poor little ura is up the creek without a paddle. go stick your head back in those financials and continue to sing you gloom and doom song.
isn't your suggestions to break from the current strategy to go it alone on cabo? isn't your suggestions to monetize on our assets either by selling or partnering it now, even when it will most likely be at distressed terms? aren't those your wonderful ideas? aren't you telling the company to give up on their go it alone strategy; isn't that the same as asking the company to fold? i.e. don't play you current hand anymore and let's do something else even if that comes at a higher future cost.
You seem to be averse to risk which is moronic that you would be investing in this sector where most drugs end in failure and company in liquidation. unlike you, i'm ready to loss most if not all of my investments if it turns out that i'm wrong with the GAMBLE. So, no, even if METEOR flops, i won't be in the same place as you b/c once i loss faith in a company, i sell (taking my losses) and move on, not stick around and cry over spilled milk like some little baby. that's how big boys play this game... if you can't deal with the consequences then you shouldn't be investing in this space.
So, if you think MM can't turn around this ship, you should sell or even better yet, you should short... instead of crying for change that will never happen on a useless message board.