maddog, it seems you're getting cold feet. if results are not released by tomorrow, maybe you should sale your position. there's nothing wrong with that. not everyone is cut out for this sort of risk.
sarcoma can be both low-grade and metastatic though the odds are really small... like only a few percentage.
i don't think they release baseline data for picasso 3, so we don't know how sick these patients were. Therefore, i don't think we can read much into their results.
drscott, here's why the layoffs are not a concern.
first, for a company that doesn't do any R&D and only has one drug in clinical trials and other drugs being managed by partners, there's no reason why they should have as many employees as they did. There must have been a lot of fat in the organization.
second, contribution from cobi will top off at around 100MM with only melanoma and won't be a huge revenue stream until it's approved for more indications which will be years away. So, without revenue from mCRPC, there's no way exel can keep the fat.
seman, you're a funny clown. you act like an expert but you can't figure out the simplest things, needing things to be spelled out for you.
Did you not know that drug sales are a high margin business and that profit sharing or rev/cost sharing at the end of the day basically gives you the same bottom line? how many drugs can you name that is a money loser? i'm waiting...
the 6.6MM is attributed to the USA and it doesn't matter if the sale was for stocking shelves... the distributor will stock what it thinks will sale in the near term. to the company, it all gets added to revenue. So don't go confusing yourself with all this talk about units, potential competition, pricing or what not. nothing more clear than booked revenue and growth trend.
Timeline? really, you need the timeline to be spelled out for you also? Thought an expert like you would have known the timeline in drug development to sales is always in years. just like debt payback. So, as long as the creditors sees success in trials they will not have any problems rolling the debt. RCC(eta 2015) and HCC(eta 2017) results will be out b/f debt comes due starting 2018 i.e. no bankruptcy so long as the existing trials are successful.
so, what other question does mr. expert have?
seman, yes, you're using facts to lie. what you say are relatively true, but you distorting the truth? will the daily burn rate continue to be 800k with the current layoff? So, the CFO is gone but they do have an interim in place to manage the books. So, Cabo failed a trial but did the mCRPC trial have a leg to stand on from the start? The OS they use to justify going to phase III was only 3 months longer than the historical 7 month. Not really a strong proof of os efficacy. The current Pivotal trails have shown much stronger efficacy compared to historical so there chance of success are much better than a coin flip. Yes, the stock is getting a beating, that's why it's a cheap stock considering the potential for future success. bash away basher.
seman, here's a rough conservative breakdown for rev for exel.
MTC: 6.6MM/qtr is 26MM/year and still growing. but assume same sale in EU and we have ~50MM on the low end.
Melanoma: 60MM/year assuming similar Zelboraf of 400MM/year. So, only assume a 30% cut of use sale of about 200MM we get 60MM. analyst has projected peak sale of around 700MM
RET+ NSCLC: 80MM/year assuming half of the 2000 incidence at cost of 80k/year
Nexavar comparable: Most of Nexavar sales are in RCC and HCC with global sales of around 1 Billion. Assuming Cabo is successful in RCC and HCC the same efficacy shown in early studies, it's not unreasonable to assume it will generate revenue similar to Nexavar. but lets say we only generate a third of Nexavar's revenue, that would still be 300MM.
So. there you have it. 50MM + 60MM + 80MM + 300MM = 490MM. A conservative estimate with room to grow if cabo and cobi are successful on their current pivotal trials.
seman, nothing to stop it from falling? how about complete ownership of a drug that has shown single agent activity in multiple indication that has already been approved in a small indication and is currently in 2 pivotal trail with near term readout? or strong revenue sharing interest in a second drug that has succeeded in a phase III trial that will be approved and will have follow up trials in other indications with strong science to support success?
if Exel succeeds in its existing trails (with early stage data to support strong activity), you're talking about a company with at lease 500MM in revenue. This kind of revenue can easily support the current debt levels. we're not even factoring in the fact that these two drugs have potential to be active in other indications since they are in multiple early stage trials. Or that they have a few partner drugs that are in phase II trials.
You know as well as I that exel has bottomed but do continue to talk the stock down since i'm sure there are fools who have not done their DD and will probably be scared by your bullsh!!!!t. I'm always opened to buying more at lower prices. continue the good work basher
20% in the phase II trial went on to take votrient.
since the phase III trail is international, os for eu sites should have the added advantage of trabectedin.
f my guess is correct, the treatment arm should have more patients strong enough to continue onto second line.
Two limitation of extrapolating from the EORTC trial is that they had a different mix of subtypes and chemo regiment used. However, these two difference would not have resulted in the huge difference in survival seen between the two arms. What this does mean is that the os for the control in our pivotal trial could look different from what was shown in the EORTC trail but i wouldn't expect the difference to be significant.
maddog, You've brought up good points that i too have questioned at one point or another. After a lot of DD and consideration, i've reached some conclusions regarding these issues.
1. i think the maintenance option contributed to the high rate of patients moving on to second line chemo. reason why patients don't move on to second line is usually b/c they are so beat up after going through firstline that they are too weak for additional therapy. with the option to take a less toxic drug for maintenance after finishing the combo probably allows the patients to hold off their disease while at the same time recover their strength. of the 59 patients that received 6 cycles for combo, 48 went on to maintenance. So, a high percentage, about 81%, of those eligible to go onto maintenance did so. factor in the fact that those who went on to maintenance had slightly worse baseline characteristics than the treatment arm and it's reasonable to think maintenance was probably popular among the sicker patients.
2. os from second line and firstline are not additive. those that go on to second line are among the healthier and stronger of those that go into firstline. a lot of patient dont' survive firstline or were too week to continue to second line. So, votrient's second line os doesn't change the expected os for dox in firstline. it should also be noted the os for votrient in second line STS was not statistically significant compared to the 10 months os in the control arm and that it was approved based on pfs.
3. with so many studies in STS, you're going to see survival all over the place. All these studies are going to have different enrollment criteria so they will no doubt have different baseline characteristics. So, it's not strange that you will get a study with longer than expected os. The question is for similarly sick patients, what os is expected. The only recent trial we have with similar baseline to ours is the EORTC with 12 months.
beach, selick did say it was "coming up in the next couple of weeks". with the operative word here being 'couple" or two. so, it wouldn't surprise me is this is the week but we've already waited so long so what's a few more days.
seman, who are you trying to kid? how can we not feel the overwhelming love and kindness emanating from your posts. if you're not worried about our financial well being, why else would you spend EVERY waking moment here trying to convince us exel is DOA. speaking of doa, there are really a lot of sick people who would benefit more from you donating your organs; stop wasting you time here on a lost cause. there's someone out there in real need of your liver, kidney, and heart. hurry, your life can finally be put to some good use by saving someone more deserving.
seman, thank your kind heart for trying to save us ignorant investors from ourselves. but don't you think there are more deserving people out there who would benefit more from your good work. like, feeding the homeless, going to Africa to help with the ebola outbreak, joining greenpeace to save the environment, and perhaps the most important thing you can do for human kind is DONATE your organs to the sick.
ml, market cap is a measure of hype -- nothing more. the hype or lack of is not a predictor of trail success. e.g. exel and ziop was hyped for success and we know how that turned out. in contrast, the market had bet against dndn and arna but both came out on top. my point is ignore the noise and do your own DD.
volnay, each to their own, if you can consistently time a stock to make 30k/month every month, more power to you. but i doubt you can do that consistently with a stock like thld with it's low volume and volatility. but who am i to doubt. good to know you were not gloating over such a small trade.
ml, who said interim was a slam dunk? there's no certainty in biotech investing but i've gone on record of saying that the sts interim has a very good chance of succeeding; much better than a coin flip but by no means is it a slam dunk.
i came to my conclusion, from the body of evidence regarding this trail from: the phase II data on sts, phase 3 STS trial design, current standard of care for STS, enrollment of the study, all preclinical/clinical data from th-302, the science behind th-302, the company's posturing and my instinct that i've built up from many years of biotech investing.
So, you go ahead and do what works for you by playing the odds instead of doing DD on individual companies. But be warned, this approach of yours isn't a slam dunk either.
volnay, can't fault any one for making money trading but should you be gloating over making 30k? let's assume you started building your position at the start of the melt down which was around may. making 30k in four months isn't at all impressive. this wouldn't even amount to a 100k/year salary.
thousands of momo traders? really? that's why the stock is up only 25% from it's latest trading range and still below it's normal trading range of mid 5s b/f the biotech meltdown. So all these thousands of momo traders must have collectively bought like what? 1MM shares? WOW, that's sure a lot for fuel for panic selling.
Don't hold your breath waiting to get in cheap b/c when the interim is stopped for meeting it's endpoint, you'll be on the sideline watching the stock fly right by you. if you're lucky, you may be able to buy in the teens but you better act quick or that will pass you buy also.
exel was over valued at 8 considering success in mCRPC was baked in and there was no meaningful evidence that it could significantly extend survival in this indication. Cabo was hyped for strong efficacy in mCRPC and when it didn't deliver at interim, reality kicked in and the stock dived. now under 2 with two proven drugs, the risk reward for exel is good -- much better than it's ever been.
in contrast, STS success is definitely not priced into thld considering the market cap is under AF's magical 300MM. So, i wouldn't expect thld to dive (and it could possibly rise) with trial continuation at interim.