When I combine your statement "Now they will need to find effect of the drug on overall survival"
with dcaf's statement "primary completion date slipped from Dec 2014 to Jul 2015"
I get "the patients live longer than expected"
Does that make sense?
If Sandoz can displace Leucovorin with generic Levoleoucovorin they have a sizeable business opportunity. That opportunity is available to them in hospitals.
"There will be no material impact on Fusilev revenues regardless of the patent outcome".
He cannot say that, but we can think it: If (1) hospitals get paid for procedures and clinicls get paid for the drugs they use directly and (2) Spectrum does most of its Fusilev business with clinics, then the impact on Spectrum's Fusilev revenue should be correspondingly low.
Could doctors prescribe generic Fusilev off-label for the main indication? What is their exposure if they do?
I doubt it. They are unlikely to combine that with an earnings call, it's too big a deal. Would love to see a SPI-2012 partnership with big pharma though. Oh well, we can dream.
Easy to look up. You can look at their balance sheet either on Yahoo finance or on the company's web site. No need to ask questions about it.
"...We need something new to discuss ..."
I am confident that Spectrum's management knows that they need to give significant, material and new (dar I say game changing) information to justify inviting money managers who matter to spend two hours of their time with a company with a market cap of $400 million.
If this event turns out to just be damage control after the Fusilev ruling, the share price will take a beating.
"a horrible mistake". Absolutely, unfortunately too many constituencies repeat it today - all over the world and in all walks of life.
If the desert were had running hot and cold water, room service, and air conditioning I'd consider becoming a hermit :)
If Beleodaq sales grow to about $100 million and Fusilev sales stay intact, the stick will earn about $0.75+ per share within a year. If Fusilev sales crater (highly doubtful) CE Melphalan sales will compensate assuming approval (also highly likely) next year. In the meantime there is is enough cash on hand to weather any storms.
I do not consider this a speculative stock, given the company's cash position, revenue stream, and late stage pipe line. I view this as an early-stage growth company, Fusilev setbacks notwithstanding.
"we had to hear some classical "Vorurteile" against germans here already"
Yes, and against just about any other group you can think of. Usually followed by some diatribe without any informational value whatsoever. Its just flotsam that washes up in this message board occasionally. Walk around it, not through it.
From the ONXEO news release:
"Beleodaq® by the Spectrum Pharmaceuticals’ oncology sales team has started in late July 2014 with positive level of sales estimated to around 5M USD"
The operative word here is "estimated". Why not wait until March 13th. We'll know actual revenues then.
"Telesta Therapeutics (TSX: TST) intends to file a BLA in the first half of 2015 for its mycobacterium phlei Cell Wall-Nucleic Acid Complex (MCNA) product that works similarly to BCG. Spectrum Pharmaceuticals (NasdaqGS: SPPI) plans to file an NDA for EOquin in 2015, despite failing to meet the primary endpoint in two pivotal trials. EOquin is an analog of mitomycin C, a chemotherapy already in use
for bladder cancer. Both candidates are delivered intravesically."
Sounds like (a) Eoquin might be another weak patent and (b) it has to compete against other new drugs that will come to market before Eoquin is approved.
"Zevalin is being launched in Hong Kong this year in 2015"
Wow. How did the pull that off, given the lengthy approval process?
I don't know if preexisting clinical trial data from the US can be used in China to support the Chinese equivalent of an NDA filing, and, if so, how long the approval process typically takes, Can you shed light on this?
Beleodaq is indeed the wild card. If sales growth is robust, stock price should follow. We'll see in March.
CASI has not yet proven that they can (a) get our drugs approved in China and (b) sell them there. It's early days, the jury is out.
"Why is he ignoring that there is a real threat that they lose some or most of the fusilev revenues."
He isn't. He said that Spectrum can scale down their burn rate very rapidly if they have to.
Also, according to my recollection: in the clinical setting, where most Fusilev is sold, and Oncologists earn a percentage of the drugs they sell/use, it makes no economic sense for them to use a cheaper generic drug unless that drug is specifically indicated for colorectal cancer.
Tartiaboy's response sums things up very nicely. I only want to add one thing. Raj's agility saved the company 15 years ago. This is in fact in the past but definitely applies now as well as then. I think the company is in good hands (his style and occasional exaggerations notwithstanding).
Of course, the fact remains that the company has transitioned from a speculation into a going concern and could now benefit from new leadership (without the baggage).