I Good Good Study, SPPI Day Day Up

仁者深潜

After a diligent research and study on the drug Zevalin that was initially approved for the treatment of patients with relapsed or refractor non-Hodgkin's lymphoma. ,
I am very upbeat about the prospect and prosperity of the drug company Spectrum pharma as a whole rather than the near term FDA decision on the drug. Further, I like to
write down a few facts about the drug Zevalin in a bid to have a better picture of the drug company.
Fact No.1:
technically speaking, the drug company has filed a FDA review of supplemental Biologics License Application [sBLA] for the drug Zevalin, which usually
has a greater approving rate than ceonventional NDA filing.

Fact No.2:
Zevalin has been approved only for the treatment of patients with relapsed or refractory NHL(non-Hodgkin's lymphoma)  . In 2008, the clinical trials showed
the significant success of Zevalin as a　consolidation therapy combining with other durgs or first line chemopherapy to cure NHL.　

"The FIT data speaks for itself. Patients achieving a complete remission (CR) after induction chemotherapy who received ZEVALIN consolidation achieved a median progression-free
survival benefit of greater than 67 months, compared to 30.8 months in the control arm," said Rajesh C. Shrotriya, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals.
"The addition of ZEVALIN as a consolidation therapy could represent a significant advancement and a changing treatment paradigm for patients with NHL.
Source: http://phx.corporate-ir.net/phoe ... 3569&highlight=

Fact No.3:
In 2008, Spectrum Pharma filed the sBLA as a first-line consolidation drug that, if being approved, will be a great deal for the company to make a huge potential
profit.

"Assuming the sBLA is approved, which appears likely based on the European Commission decision, Spectrum Pharmaceuticals stated that Zevalin’s addressable
patient population would increase by approximately 18,000. At an approximate cost of $25,000 per treatment, the additional market for Zevalin would be worth
$450 million. Not bad."

Source: http://seekingalpha.com/article/ ... a-action-on-zevalin

Fact No.4:
Zevalin has been approved in Europe a year ago as a first-line consolidation drug, which likely will be a positive influence to the FDA drug review panel. On the top of that,
the rising profit will certainly benefit its investors.

"In April 2008, the European Commission extended the marketing authorization for Zevalin in Europe to include first line consolidation therapy for patients with NHL..."

Source: http://seekingalpha.com/article/ ... a-action-on-zevalin

Fact No.5:
The drug company recently bought  half of the Zevalin drug commercial right from CTIC, which makes Spectrum Pharma the sole company with 100% ownership of the drug. What does
it mean? It reflects that the Spectrum Pharma has already ruled out its strategic plan to market the drug and its confidence on the drug sustained with company's strong financial condition and its holistic preparation

Fact No.6:
The company has filed another NDA for a cancer drug and the FDA action date is Oct,2009. So, stockholders will get off the hook easily in case Zevalin being denied or delayed.
That means that the stock price will be sustained above $5 or $6 in the worst scenario.

Fact No.7:
Solid financial support from a large numbers of financial institutions. The most recent $21 million of securities purchase from institutional investors.

Fact No.8:
There are other clinical trials on the list and the list still goes on.
Source:http://www.spectrumpharm.com/products_Spectrum.html


Fact No.9:
Even if the FDA grants the sBLA, still, the company has to manage to penetrate the market due to the few oncologists mentally recognizing radiopharmaceuticals. The prodeccesors of Spectrum Pharma
failed to market the Zevalin.

Hope that it will be helpful. But YMYD and YTYD..

seabiscuit

以严谨的态度来研究股票，值得称赞。  谢谢你的信息。