RiverBabe's Baby Biotechs

[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]

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..."

[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.

[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?

[dmk112]

River, besides DNDN - which one of these are you holding? They have a place close to my house in Morris Plains, maybe I should apply for a job there....ha! Also, I recommend checking out johnwelshphd on twitter, he trades biotech very often and has been very profitable doing so.

[riverbabe]

Vvus

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?

One positive follow-up study doth not an FDA approval guarantee. Reading further about both VVUS and ARNA gave me goose bumps. Both of these are way too volatile for my comfort zone.

[riverbabe]

Dndn

River, besides DNDN - which one of these are you holding? They have a place close to my house in Morris Plains, maybe I should apply for a job there....ha! Also, I recommend checking out johnwelshphd on twitter, he trades biotech very often and has been very profitable doing so.

Yea! A job at DNDN, go for it if there's something you would be interested in! They just inked a deal with Glaxco Smith Klein for manufacture of the antigen. I think they're an up and coming takeover candidate maybe.

I locked in a good profit in DNDN and am waiting for another pull back to re-enter. I have ALXA (imminent FDA decision) and BMRN (possible TO candidate). And sitting on some DCTH (red) waiting for filing of an FDA application -- looking for lots of good news in third or fourth quarter.

I'll look at johnw. Thanks.

[dmk112]

Yea! A job at DNDN, go for it if there's something you would be interested in! They just inked a deal with Glaxco Smith Klein for manufacture of the antigen. I think they're an up and coming takeover candidate maybe.

I locked in a good profit in DNDN and am waiting for another pull back to re-enter. I have ALXA (imminent FDA decision) and BMRN (possible TO candidate). And sitting on some DCTH (red) waiting for filing of an FDA application -- looking for lots of good news in third or fourth quarter.

I'll look at johnw. Thanks.

Cool.. what is your strategy on buying these? Buy a few months before the event, hold, and sell before the decision?

[dmk112]

I'm getting into this lol.. Do you have PDUFA date calendar by any chance?

A few I found that are interesting with PDUFA dates coming up in the next few months along with some bottoming patters:

CPIX MNKD

[dmk112]

Bought a small position of ARNA today @ 1.72... looks like it bottomed. Also scaled in AVNR.

[riverbabe]

Cool.. what is your strategy on buying these? Buy a few months before the event, hold, and sell before the decision?

Buy not before 6 months ahead. I usually average in, usually down. Keep track of whether they are "fast track" at FDA, meaning they have constant dialogue with FDA before decision so that they can correct problems ahead of time. Watch rivals with parallel technology with FDA decision ahead of yours. Sell on any spike before decision only if you're unsure because of rival decisions. Keep up with the news, email alerts, web site. Watch the pundits for their views on it's chances. Again, sell on spike only if you get cold feet and are well into the green.

But if you are nimble and quick you can catch the decision immediately when it's made only by watching the stock price, because the actual news lags by too long. If it leaps up, it's positive. If it plummets, get the he$$ out STAT.

Plummet -- quick but tough decision, market or limit. It's going to blow through a regular stop sell and it will become market. Limit? it might not hit twice. Panic? market STAT and thank god you got out with a sizable piece of your shirt intact.

[riverbabe]

Fda/pdufa

I'm getting into this lol.. Do you have PDUFA date calendar by any chance?

A few I found that are interesting with PDUFA dates coming up in the next few months along with some bottoming patters:

CPIX MNKD

This is an interesting link for those who are not aware, to "what is a PDUFA?"

http://www.eyeonfda.com/eye_on_fda/pdufa/

The FDA does not publish a calendar because the info. is proprietary to each company. But there are blogs and web sites out there that put together calendars. There is one on you friend welsh's twitter, but it is not very complete. Adam Feurerstein puts together an abbreviated calendar for what he considers the ones he's interested in. I don't invest in each and every one, so I just find calendars as they become available on the web, not very methodically.

[riverbabe]

I'm getting into this lol.. Do you have PDUFA date calendar by any chance?

A few I found that are interesting with PDUFA dates coming up in the next few months along with some bottoming patters:

CPIX MNKD

I posted about MNKD below. Will look at CPIX a little later, busy right now (real work, 'ya know?).

[riverbabe]

Fda Advisory Committees 2010 calendar

http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

These committees recommend to the FDA. A negative recommendation is not good.

Below: who met with whom calendar. Note second one lists a meeting between DCTH CEO and FDA official.

http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/2010PublicCalendars/default.htm

http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/2010PublicCalendars/ucm226533.htm

[tiedyed1]

Vphm?

Hi River;

VPHM came up on Pete's list years ago and has recently made Mr. Markets data dump numerous times this year.

This stock looks like it is starting to make a move and may be worth looking at and I would appreciate any opinion you may have on this one.

Thanks so much; -Adam
tiedyed1