RiverBabe's Baby Biotechs

[dmk112]

been watching VVUS... bought it the other day, got stopped out, and of course today it soars

River, what are your latest thoughts on this one?

[riverbabe]

billyjoe

ATHX-hold agree, no immediate impetus on horizon to boost price, in Phase 1 clinical trials

CPRX-hold agree, Phase 1 and IIb clinical trials, no immediate impetus seen

CYCC-hold agree, waiting for FDA approval to begin Phase 3 clinical study

AVII-hold agree, studies are all in animals but one, all preclinical, long wait to come, but promising

DUSA-hold this guy likes it but admits he has a large long position, so beware, pushing it. http://seekingalpha.com/article/2223...h?source=yahoo Oops, FDA denies "orphan" status to one of it's candidates. Hold seems to be the best bet but put it on your watch list

RNN-sell agree, is this dog still around? still hyping Phase IIb clinical studies; long wait here; put your $$ elsewhere

INHX-sell agree, in Phase 1 and II trials; long wait here; put your $$ elsewhere

LUNA-sell agree, declared bankruptcy a year ago but came out; founder CEO just retired; looking for new CEO. not promising yet

CUR-sell agree, wonder who picked that name? Phase 1 clinical study FDA application; long wait here, put your $$ elsewhere

billy, don't know who your guru is, but he/she pretty much nailed the above.

[riverbabe]

Dndn

This is a good example of the hoops a biotech. company has to go through after FDA approval (DNDN). I'm still in at 36.93 av.

http://www.fool.com/investing/high-growth/2010/09/01/dendreon-one-step-closer-to-worry-free.aspx

Dendreon: One Step Closer to Worry-Free
By Brian Orelli, Ph.D. Sept. 1, 2010

"Dendreon Corp

Watch DNDN CAPS Rating 2/5 Stars . $39.06 $0.82 (2.14%)

Getting a drug approved may be a marathon, but the battle isn't over when the Food and Drug Administration slaps an approved stamp on the marketing application. Drugmakers still have to get their drug paid for. Lack of coverage by insurance companies or government agencies can severely dampen the potential customer base.

Dendreon's (Nasdaq: DNDN) investors understand that all too well. The company has secured reimbursement from quite a few insurers -- Aetna (NYSE: AET), Humana (NYSE: HUM), Kaiser, and others -- but hasn't landed a final decision from the big Kahuna: Medicare.

Back in July, the Centers for Medicare & Medicaid Services (CMS) announced that it planned on reviewing the reimbursement for Dendreon's prostate cancer treatment Provenge. The process is supposed to take about a year with a proposed decision by March 30, 2011 and a final ruling in June 2011..."

[Peter Hansen]

Alxa

Hope to get time to look at some of these today or tomorrow.

RNN shot its load........but I feel ALXA will take off next!

[riverbabe]

Soon, but not yet, the winter chill will be upon us and we'll gather around the wood burner to warm our hands and talk about upcoming biotechs. Louey Navallier sent me a list of biotechs to buy. I didn't ask for the list so it must be free for me to talk about. These biotechs are mostly in the $1.50-$2.50 range. Here they are with recommendations from another source that will not be named.

ATHX-hold, CPRX-hold, CYCC-hold, AVII-hold, DUSA-hold

RNN-sell, INHX-sell, LUNA-sell, CUR-sell

They can't all be stinkers. What do Mr.Market members think?

------------billy

Hope to get time to look at some of these today or tomorrow.

[riverbabe]

River,
Do you see ALXA and MNKD being in the same boat as far as FDA approval/disapproval on the horizon? Mr.Mann has put over 1 billion of his own fortune on the line. Quite a show of confidence in the inhalable insulin product.
---------------billy

billy, Mannkind got a shock when Afreeza was not approved by the FDA in March 2010. They are now doing another Phase 3 clinical study:

"Evaluate Safety of T/I on Diabetic Subjects With Mild Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified by Mannkind Corporation, August 2010
First Received: March 21, 2008 Last Updated: August 3, 2010" www.clinicaltrials.gov

But this article talks about another opportunity for FDA approval on or about December 29, 2010. http://finance.yahoo.com/news/Good-N....html?x=0&.v=1

"MannKind Corporation (NasdaqGM: MNKD - News) received a boost when the US Food and Drug Administration (FDA) accepted MannKind’s response to the complete response letter (CRL) issued by the agency on its inhaled insulin candidate, Afrezza. The candidate is being developed for treating type I and type II diabetes.
The agency informed the company that the resubmission will be treated as a class II review. Consequently, a decision from the FDA should be out within 6 months (target date: December 29, 2010). The resubmission included safety and efficacy data from recently completed studies on the candidate..."

This an interesting article about new financing obtained by Mannkind on Aug. 19th. http://www.fool.com/investing/value/...e-10-nice.aspx Hmm...

Mannkind does not have any partners in Afrezza development.

FDA approval for this type of deep lung inhalor will not be easy for MNKD. The company is hanging its hat on approval or it could possibly go bust, Mr. Mann's billions or not. IMHO it's still a crap shoot at this point.

ALXA also is seeking FDA approval for their first product delivered by a deep lung inhalor (on or about October 11, 2010). They have also recently acquired a partner (Cypress Bioscience) to do the R&D for their nicotine inhalor using the same technology.

Frankly, since there is a parallel technology to MNKD's, Alexza may also have trouble getting a yes from the FDA on the first try. At this point, I'm leaning toward selling on a run up prior to the FDA decision.

[billyjoe]

River,
Do you see ALXA and MNKD being in the same boat as far as FDA approval/disapproval on the horizon? Mr.Mann has put over 1 billion of his own fortune on the line. Quite a show of confidence in the inhalable insulin product.


---------------billy

[billyjoe]

Soon, but not yet, the winter chill will be upon us and we'll gather around the wood burner to warm our hands and talk about upcoming biotechs. Louey Navallier sent me a list of biotechs to buy. I didn't ask for the list so it must be free for me to talk about. These biotechs are mostly in the $1.50-$2.50 range. Here they are with recommendations from another source that will not be named.

ATHX-hold, CPRX-hold, CYCC-hold, AVII-hold, DUSA-hold

RNN-sell, INHX-sell, LUNA-sell, CUR-sell

They can't all be stinkers. What do Mr.Market members think?

------------billy

[riverbabe]

River,
How about ENDP? Just signed an agreement to buy out PPCO at $5/share and it looks good to me.

------------billy

Endo Pharmaceuticals is a great established pharma. Their move on Monday to buy out Penwest to reduce their royaltay payments and add to their pipeline is a smart move IMHO. So, the question becomes, when is the best time to buy?

The price got a nice boost on the news Monday and hit its 52-week high (26.05) from Dec. 2009 on Tues. But it couldn't hold it because of market conditions yesterday. It pulled back to another resistance point that should act as support now (around 24.96-25.00). (stockcharts is acting squirrely this morning, so I'll try to post an annotated chart. But if I can't, look at the weekly in particular.)

I think the news is priced in now, and from here it will move with the d$%@ market. Keep an eye on the 200. If it breaks it, it should fall dramatically. I'd try for a low-ball bid here. JMHO.

[billyjoe]

River,
How about ENDP? Just signed an agreement to buy out PPCO at $5/share and it looks good to me.

------------billy

[riverbabe]

Dndn

Back in Dendreon. Blow-out sales of Provenge. Av. 36.93. Wow.

http://investor.dendreon.com/phoenix.zhtml?c=120739&p=irol-newsArticle&ID=1455982&highlight=

[riverbabe]

Pbth

Whats your thoughts on pbth now. I bought it at 6.30, sold at 8.30, then i bought again at 6.65 and it ran up to about 7.35 and now its back at 6.70. Not sure what to do here, i think the company has good long term potential though and i would like to stay with it.

I think you should stay with it. It is consolidating after the recent run-up, similar to what it did before (circles). Also it has support at 6.50-ish (pardon my not-so-straight support line). If the market keeps going up, it should move with it.



Watch the narrowing Bollinger Bands on the daily, indicating low volatility. It will move one way or the other dramatically very soon (walk down the lower, or walk up the upper). All the other indicators are moving sideways on low volume, indicating consolidation. Stoch beginning upturn from oversold.



News on re. new Phase II clinical trial with Human Growth Hormone, July 21st.http://www.prolor-biotech.com/_Uploa...lOfhGH-CTP.pdf

[TheRelapse]

Whats your thoughts on pbth now. I bought it at 6.30, sold at 8.30, then i bought again at 6.65 and it ran up to about 7.35 and now its back at 6.70. Not sure what to do here, i think the company has good long term potential though and i would like to stay with it.

[Peter Hansen]

Cypb

River CYPB is running nice ....check it out!

[riverbabe]

Pete - BVF

River check out BVF ......Vector Vest says it is UNDERVALUED and should be worth about 24 bucks. BVF also pays an annual dividend of $1.40 Per share ......and the chart is popping!

Funny you should ask. Biovail is a partner of ALXA (I have a stake in ALXA). I don't know whether to laugh or cry about this company. I have a long memory. The stock is on a tear after its (many) Valeant merger announcement(s). http://www.nytimes.com/2010/06/22/business/22drug.html
But-----

http://www.prlog.org/10764365-valeant-pharmaceuticals-international-investors-file-lawsuit-against-biovail-takeover.html

http://www.bloggingstocks.com/2009/08/24/biovails-short-selling-lawsuit-dismissed/

http://www.bloggingstocks.com/2008/05/20/biovail-another-naked-short-selling-poster-child-exposed-as-an/

http://www.news-medical.net/news/20090824/Biovails-patent-infringement-lawsuit-against-Cary-Pharma-may-affect-IntelGenx-revenues.aspx

As a matter of principle, I dislike companies that keep suing other companies or keep getting sued. My eye is jaundiced, sorry. I won't be investing in it. And I won't be reviewing it further. It might be okay now. But take it with a grain of salt.