I believe the first generic approved for a patented drug receives 6 months marketing exclusivity. If so, that could be the motivation to file an ANDA for Fusilev so early.
The disease for which Beleodaq is indicates has not long-term effective treatments. Every 18 months or so the drug currently in use stops to work and a different one is needed. What results is a rotation from one drug to he next over the course of the disease. Beleodaq is part of that rotation - given its benign side effect profile it should become a preferred choice for frail patients. Well, that's my understanding anyway, maybe someone more qualified than me (doctor, chemist, pharmacist) among us can confirm, dispute or refine what I said.
Is there any chance for a surprise from Zevalin now that Bexxar has left been withdrawn?
Years ago during the first round of Eoquin buzz two numbers were thrown around as if they had some merit: 60,000 potential patients per year and $30,000 per course of treatment. Don't know where they come from or what merit they have (maybe someone else does). I don't remember anyone arguing with those numbers though; they must have had some sort of legitimacy.
I won't even consider adding until I see marked improvement in the company's financial performance. It's necessary and overdue.
It is no longer enough to brag about approved drugs that are commercial duds and cost (almost) as much to market as the revenue they bring in.
"Superficial analysis of past." True, but they do have a point. The company's finances are impacted by two significant items: Increasing RND costs - 26M to 46M in the last 3 years, and increasing selling and selling, general and administrative expenses - 72M to 99M in the same period.
I understand and accept increasing R&D expenses; that's how drugs are developed. However, S&G expenses are growing dangerously fast. Since they don't list anything as one-time expenses on their income statement (on Yahoo) I suspect they intend to keep spending money in accordance with existing trends. Increasing expenses while sales are decreasing is often a recipe for disaster.
The decision came more than a month ahead of schedule - and on the day before a major holiday. Maybe they were simply surprised and unprepared.
The announcement includes: "Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial."
Do you know whether the word "may" in the quote above indicates that this trial is required or not, Tartiaboy?
"I believe that discussion of Raj's remaining or leaving is more of a distraction than a relevant topic."
True. I have no expectation of any action on that score. Still, I find this distraction interesting to explore on its own merits (one of the little indulgences I allow myself).
"We will be rewarded for steps forward, not for potential."
What would be (a) the advantage to the share price, if any, of the CEO's departure and (b) the disadvantage to the development of the pipeline and running of the company?
I know that's an impossible question to answer conclusively, but it would be interesting if there is any consensus about this at all.
My take on this: Given the current state of Spectrum's drug development, Dr. Shrotriya's departure AFTER the SP-2012 and Eoquin Phase 3 trial designs would not have a significant effect on near or intermediate term pipeline development efforts. On the other hand, his departure may give the company's management a chance to regain some of the credibility that has been lost. Therefore I think his carefully timed departure would be advantageous overall. He should go, say, shortly after the Eoquin NDA submission (not that I expect that to actually happen).
With a hundred sites and a disease occurrence of about 60,000 per year they should be able to fully enroll this trial in less than 3 month - true or false?
"Spectrum not starting the new study ASAP, knowing that’s what it takes to get the NDA process going, speaks volumes to me."
Could be a simple cash flow issue: Pick the projects that increase cash flow soonest and drain current reserves least. That strategy would only delay Apaziquone slightly and minimize the potential of future dilution.
A number of years ago Spectrum was in the generic business to pay the bills.They were the first company to file an application to produce a generic for a drug(someone else's) whose patent protection was expiring. The benefit to Spectrum for doing this before anyone else was a 6-month exclusivity period during which they were the only ones who could market a generic version. If memory serves, they sold that right for $20 million to some other company. Maybe someone else can fill in some of the details here.