Spectrum: FDA News on Zevalin Equals an Approval

Spectrum Pharmaceuticals (SPPI) received a Complete Response letter from the FDA regarding its supplemental biologics License Application (sBLA) for Zevalin® (ibritumo-mab tiuxetan) for first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients.

The FDA’s letter requested that Spectrum submits data files from the FIT study to support and verify a subset of the data that are currently under review for the proposed labeling. Many investors got disappointed, or pretended to be disappointed, and caused the stock to fall, rather than to be boosted on the good news.

The truth is that, we, and most people who follow up on the biotech industry believe that the response is extremely good news for Spectrum. The response is almost equal to an sBLA approval. As a matter of fact, the FDA did not request any additional clinical studies. It did not request clearing of any misunderstanding of the data presented by Spectrum and more importantly, it did not even request any additional new analysis for any data.

That’s why the firm believed it could formally respond to the FDA’s requests by this Wednesday, July 8, 2009, i.e., two days from now. The requested data is probably available, but the firm might have believed it was not essential for proving its point That’s why Spectrum is confident that the data it will submit will satisfy the the Complete Response letter's requirements and, to expect a favorable regulatory decision.

Zevalin, we knew, does not need safety trials, as the drug has been approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.

Our opinion is that the news from the FDA is good and that Zevalin's sBLA will be approved.

Maybe the recent selling of the stock gave a short term opportunity for the short sellers to breathe before the sBLA approval, which we expect now more than anytime before.

Disclosure: Long SPPI

Comments

[David Zanoni:]

I think that you are right-on. Today presented a great time to get into SPPI during the sell-off. I would expect the stock to move significantly higher once the final approval is announced.

Jul 06 05:55 PM

[Michael Cat...:]

Great article, would you be interested in having me publish this on StocksHaven.com and thus press releasing it on Google News as my website is connected to it. Contact me at michaelvlaicu@stocksha...

Thanks,

Michael
StocksHaven.com

Jul 06 09:35 PM

[adenovir:]

The only question is how long will it take for the approval to happen. 6 months, 60 days, or something much quicker?

Jul 07 09:52 PM

[sppi_analyst:]

this old kook is off his rocker if he or anyone believes a delay and non-approval "equals approval."

my grandfather too invests in highly speculative biotech stocks. i always take his investing advice.

hilarious.

Jul 08 09:52 PM

[orest:]

sppi ANALyst, you flooded enitire internet with your trash? What makes so so obsessed with SPPI??!!

Jul 08 11:40 PM

[sppi_analyst:]

this stock will break through $5 by next friday and drift lower heading into August, which is usually a time when stocks are thinly traded and trend lower. i can't wait to read all of the "buy more now" and "thanks for the cheap shares" and "news coming" posts to try to prop up this POS.

this stock can't hold $5.50 so it's a pipe dream that it does anything but drift lower.

i bet there is/was plenty of longs that recently posted positive pumper crap on this board that have either recently sold or have sell orders at prices slightly above the current stock price.

slow bleed heading into end of august. and, if there is even one more secondary, this stock tanks all the way to $4, as mgt will have p!ssed on any credibility that remains.

i love that i actually made a mint on this POS in less than 4 trading days when i bought 150 Aug $7.50 at $1.10 when the stock was at $6.50 and sold a few days later at $1.80 when the stock crossed $8.00. but, unlike you clowns, i realized that the rise was likely short-lived cause this mgt loves to kill a rally and because all the pumping was just that - - baseless run up supported by fantasy that Zevalin expanded label was the equivalent of a blockbuster drug. hiliarious.

clueless, clueless, clueless amateurs. i'm making boo-koo renting shares in order to write at the money covered calls while you idiot longs are rubbing your nickels together preying that they'll turn into quarters. sell this POS already!!!!! so you can sleep at night for christ's sake.

and by the way, this old geezer is nuts. what 98 yr old follows speculative biotech stocks? sure, i'll trust his analysis. probably can't remember when he put his teeth, so i'm really going to follow his analysis on some sh!tbox biotech.

Jul 09 10:29 PM

[ddigital15:]

Zevalin is definitely going to get the approval, no questions asked, it's just a matter of time. Here's a date: 7/26/09-you heard it here first....lets just say I know some people at the FDA :-)

Jul 11 11:17 AM

[ddigital15:]

Of course on 7/27/09-the decision comes out...have fun!


On Jul 11 11:17 AM User 445467 wrote:

> Zevalin is definitely going to get the approval, no questions asked,
> it's just a matter of time. Here's a date: 7/26/09-you heard it here
> first....lets just say I know some people at the FDA :-)

Jul 11 11:19 AM