Rowdy's FDA Plays ... (and pinch plays, too)... - Page 10

After looking at all the angles, I think this is already up too much to suit my taste. I think the 8/16 date will get delayed due to the pending amendment and could drop significantly on that news.

The chart is very bullish, but what is the upside? It's hard to guess because it's making 52-week highs. I think any delay news could send this back into the 5's and that makes the potential downside too great right here, imo. I could be wrong (I was quite wrong about DDSS this past week...), but I think the safe play is to hope for delay news and swoop in after the impatient traders get out.

ABIO had a huge move the past 3 days and looks "exhausted". The volume was much lower today and the candlestick pattern is one day away from a potential "Evening Star" (if you ignore the long upper wick yesterday, which is also bearish, btw). I would look for this to either test 3.25 or establish a new level of support by consolidating above there. I like to enter on support or a break of resistance so that's what I look at. That's a nice pincher, but shows how you have to play them with discipline and use more than 1 or even 2 buy signals. If you tried to predict the PPO fast/slow cross by buying on the MFI and ignoring the lack of a strong ADX +DI uptick, you might have taken a big loss without a stop.

CPE had a nice move this week without moving too much, imo; I would try to enter in the low 1.50's with a stop of 1.40. This is an oil play and I never play these without a look at the potential of oil price rising. I glance at these (every day when I have an oil stock):

http://www.metalprices.com/FreeSite/metals/cl/cl.asp
http://www.bloomberg.com/energy/
http://www.oil-price.net/

and I use a chart of an oil etf (like USO or OIL) to look at TA. These don't trade at the price of oil, but are good comparisons for a benchmark, imo.

LIZ is right at support and PCBC looks good from a daily pincher perspective. This is earnings season and that deserves attention; the market sentiment on earnings right now overrides the importance of TA, especially regarding retail (LIZ) and financials (PCBC). I'm not looking to play either one of those sectors/subs right now, tbh.

These are some nice pinchers. They are dailys so I would swing trade them and never go medium-to-long without taking a good look at fundamentals. I'd find out when earnings are for each of them, too; all you need after that is a target, a time frame, and a stop. GL.

Next week's potential anticipation FDA plays

NSPH - July 31 - estimated 6-month review date from 1/09 510(k) filing for hemochromatosis (HFE) genetic test
ADLS - July 31 - Restanza (Cethromycin) NDA PDUFA decision date
NRI.TO - August 5 - NDA resubmission PDUFA decision date

I'm only playing penny stock pharmas, but there are some dates for other big board plays. I also don't look at pharmas that have had (what I consider to be) a huge run already. I thought DDSS had more room, but everyone else thought otherwise. I only mention this because that's the reason SVNT is not on my watchlist for next week. I like to look at the chart, though, to remind me of the potential in these plays:



I got stopped out of most of my DDSS today, but decided to keep 20% of my position for news. I'm not going to stop watching this play; if the date passes without news and generates a sell-off, I will attempt to trade DDSS in order to accumulate a "free ride" position.

I bought some ALDS (@ .47) at the close today; this is a risky play because the last PR that mentioned the FDA and Restanza sent the stock down more than 50%. Despite that, I anticipate anticipation. This is a small position sizing due to the fundamental risk and the volatility of these price ranges. I'm looking at an initial price target of .60 or +27%; I plan to sell 2/3 of my position at that price and then play it by ear from there. I will sell it all if it hits .80 or .40, which is my stop.

NSPH is my secondary play, but it had a huge move this past week. Holding a little NEPH, DDSS, and HGSI. GL.

8/2/09 Update

510(k)/PMA filings are estimates, as are the floats (from Yahoo Finance). Do not consider this data "accurate". Yes this formatting is lame; I'll fix it later...

I check the biomedreports.com blog and thestreet.com biotech section almost daily. I have 3 general rules for FDA plays:

1. Never bet against Feuerstein, Havrilla, or Garza.
2. Play the anticipation, not the decision date.
3. Take what is there and move on, no matter how small.

People will disagree, especially about Feuerstein. The simple fact is that these guys have lots of followers and there are a lot of FDA plays out there at any given time. It's easier to avoid picks and drugs they are bearish on than to risk that they will be wrong. Price action in relation to the timing of their articles is reason enough.

Clinical Trials 2009/10 (format in-progress)

CLINICALTRIALS
TICKERDATEEST. DATEEVENTPRODUCT/TRIALPPSFLT$/DEBTEXCHSHORT%

NEOPFDA REVIEWLYMPHOSEEK1.3670M1 / 2OB
HEPIPAZ0.4453M1 / 125OB
ACHNANYTIMEOPT-INACH-10952.0411M5 / 1
CPDANYTIMEFACILITY UPDATE3.513 / 1
OXGN2009CT RESULTSZYBRESTAT1.5120M0
CRME2009CT RESULTSVERNAKALANT4.7064M0
IVOB2009CT RESULTSINVOCELL0.3812M1 / 22OB
ONXX2009CT RESULTSNEXAVAR32.2157M43 / 1
VRTX2009CT RESULTSTELAPREVIR34.84178M5 / 1
CBRX2009ENROLLMENTPROCHIEVE1.3248M1 / 4.5
AVNR8-09CT RESULTSZENVIA2.2038M0
DVAX8 OR 9-09CT HOLD UPDATEHEPLISAV1.7928M0
PARS9-09CT RESULTSDEXTOFISOSPAM0.4328M3 / 4PK
ARNA9-09CT RESULTSLORCASERIN4.7370M1 / 2
CXM9-09CT RESULTSEXCELLERATE1.9839M1 / 5
CGCP9-09CBER MEETINGPHOENIX0.2046M0PK
CVM10-09FACILITY UPDATEMULTIKINE0.48120M1 / 1
MSHL10-09UNBLINDED ANALYSISOVATURE0.8117M0
NVGN10-09UNBLINDED ANALYSISOVATURE3.010
ARIA2Q09CT RESULTSAP235731.9079M4 / 1
ARRYMID 2009CT RESULTSARRY-1624.0545M3 / 4
GTXIMID 2009CT RESULTSACAPODENE9.4211M0
INCYMID 2009CT RESULTSINCB 184245.5996M1 / 3
ACAD3Q09CT RESULTSPIMAVANSERIN4.6230M0
RPTP3Q09CT RESULTSCYSTEAMINE0.3459M0OB
AEZS3Q09CT RESULTSCETRORELIX2.6032M0
TDLP3Q09CT RESULTSKETOTRANSDEL1.4010M0OB
NVAX3Q09CT RESULTSTRIVALENT VLP4.9073M1 / 1
CHTP3Q09CT RESULTSDROXIDOPA4.6821M2 / 1
VVUS3Q09CT RESULTSQNEXA7.0069M9 / 1
PARD3Q09CT RESULTSPICOPLATIN7.4221M3 / 1
BMOD3Q09CT HOLD UPDATEASSAY DEVICE0.2374M1 / 4OB
ACCP3Q09INTERIM DATAMUGARD4.607M1 / 2OB
CYTR3Q09CT HOLD UPDATEARIMOCLOMOL1.0090M0
ACHN3Q09CT RESULTSACH-16252.0411M5 / 1
ETRM4Q09CT RESULTSVBLOC2.973M32%
AUXL4Q09CT RESULTS29.2142M0
ALKS4Q09CT RESULTSVIVITROL10.5593M4 / 1
OPTR4Q09CT RESULTSFIDAXOMICIN13.4128M0
PLX4Q09NEW FILINGPRGCD6.3928M0
SEPR4Q09ENROLLMENTOMNARIS17.41108M2 / 1
RPRX4Q09CT RESULTSPROELLEX1.3010M0
VICL4Q09CT RESULTSCMV VACCINE3.4227M0
IMGN4Q09CT RESULTST-DM17.4950M0
RPTP4Q09TRIAL STARTCYSTEAMINE0.3459M0OB
CHTP4Q09ENROLLMENTDROXIDOPA4.6821M2 / 1
CHTP4Q09U.S. MADROXIDOPA4.6821M2 / 1
ISPH4Q09ENROLLMENTPROLACRIA4.5753M4 / 3
PLX2H09CT RESULTSPRGCD6.3928M0
MYRX2H09TRIAL STARTMPC-43264.69
ITMN2H09NEW FILINGPIRFENIDONE14.5036M1 / 1
IMTN2H09EMEA MAAPIRFENIDONE14.5036M1 / 1
PSDVEND 09CT RESULTSFLUOCINOLONE2.750
MYRXEND 09CT RESULTSAZIXA4.69
ACHNEND 09CT RESULTSACH-6252.0411M5 / 1
ANDSEND 09CT RESULTSANA5982.2333M0
AGENEND 09CT RESULTSONCOPHAGE2.2056M1 / 2.5
IPXLEND 09ENROLLMENTORBEC7.8246M5 / 1
RMTIEND 09CT RESULTSSFP9.0110M0
IVOBEND 09NEW FILINGINVOCELL0.3812M1 / 22OB
BDSIEND 09CT RESULTSBUPRENORPHINE5.1015M0
BDSIEND 09CT RESULTSAMPHOTERICIN5.1015M0
ADLSEND 09CT RESULTSRESTANZA0.2735M1 / 12
CLDAEND 09NEW FILINGVILAZODONE14.4519M1 / 1
ANXEND 09NEW FILINGANX-5300.1487M0
ANXEND 09FDA MEETINGANX-5140.1487M0
RGENEND 09CT RESULTSRG10685.1725M0
CRMEEND 09EMEA DECISIONVERNAKALANT4.7064M0
CRMEEND 09NEW FILINGVERNAKALANT4.7064M0
YMIEND 09CT RESULTSNIMOTUZUMAB0.5855M0
OPTREND 09CT RESULTSPRULIFLOXACIN13.4128M0
OPTREND 09EMEA MMA FILINGPRULIFLOXACIN13.4128M0
ISPHEND 09CT RESULTSTIGER-24.5753M4 / 3
GNVC1Q10INTERIM DATATNFERADE0.7888M12 / 1
CYTX1Q10CT RESULTSPRECISE3.2127M2 / 1
CYTX1Q10CT RESULTSAPOLLO3.2127M2 / 1
OREX1H10NEW FILINGCONTRAVE7.7424M4 / 1
CYBX1H10CT RESULTSD-2117.3526M1 / 1
ATEC1H10NEW FILINGALIF3.9428M2 / 3
ATEC1H10EU LAUNCHALIF3.9428M2 / 3
RIGL1H10CT RESULTSR7888.6235M33 / 1
FACT1H10TRIAL STARTDAC HYP10.1114 / 1
CBSTMID 2010CT RESULTS20.3258M2 / 1
BPAXMID 2010CT RESULTSLIBIGEL1.8224M0
AISMID 2010CT RESULTSLIBIGEL1.0257M2 / 1
JAVMID 2010CT RESULTSERESKA1.9348M0
ISIS7-10NEW FILINGMIPOMERSEN16.5092M5 / 1

Sold ADLS @ .45; did not like that price action. Bought more DDSS @ 1.60...

Well, this is damn frustrating...I was trying to be thorough before jumping into some FDA plays and they took off without me (GTXI and ENDP). I won't chase at these levels, but I will watch for pull-backs.

Instead of those, I'm just moving onto the next one.

NSPH looks good here; it's pulled back to the bottom of a buying range and today's action showed a lot of support. This stock has dangerous liquidity, low float, and rather un-stellar fundamentals...but they also have some 510(k) filings under review with the FDA. 2 to be exact. The FDA doesn't give out dates for medical device reviews, but the best estimates for a review period end 7/31 and 8/31 for HFE and Verigne SP, respectively.

My position sizing will be on the small side due to all those factors, in addition to a super-tight stop which will be dependent on the entry (-5% or around 4.20). I'm playing a date target of July 31st and will evaluate a price target before then with an exit date before August earnings; this is a risky play and if I get stopped out, I won't look back.

Also, I'm going long (by long, I mean trading to accumulate free shares or a lot of cheap ones) on BDSI and SPPI from now until late 2010 based on revenue potential; that starts with buying more BDSI tomorrow and waiting for SPPI to pullback quite a bit... I might even pop my option cherry on these.

Oh yeah, weeeeeeeeeee!!!

Well, it was a good day to play SOMX; I was looking hard at this right after the stock offering when it was around .80...

Obviously, after today, you would be chasing; there's a significant reversal wick on the candlestick formed today, too. Not sure what drove the volume today, but it was big.

This will be a real nice gap play due to that movement on no news, imo. I would look for it to fill that gap down to yesterday's close pretty quickly (~1.36). FDA action date is December 4th; plenty of time to find a good entry.

ADLS hit my earlier price target of .60; had I stuck to my plan, I'd be a richer man...

FDA Play "Guru" Training starts now

I've mentioned before, I have some goals in trading. I've had 2 separate 3-week losing streaks in the last 2 months and I withdrew some capital (15% of it) because I wanted to...

Do not misinterpret this; I have an income and I don't trade with the money that pays the bills. I had extra money in early February and I decided to learn how to invest/trade. I haven't added a single penny since then and won't until the only debt I have left is my mortgage (a year from now, max). I was prepared to lose it all and have more than doubled it instead.

However, due to the losing streaks and reduction of capital, I've fallen behind on one of my goals. I managed to tread water during the losing streaks and have now made up half of the 15% I withdrew. To get back on track, I'm assuming more risk.

All that blabbering means one basic thing. I'm going to get back on track by becoming an FDA Play "Guru" or I'm going to take a serious beating trying; I can live with either.

I still trade pinchers, especially intraday +DI pinchers, and I will be more than happy to comment on them. As a matter of fact, when I come across a stock that is a pincher and an FDA play, I sometimes fall out of my chair. Regardless, the thread focus is shifting to FDA plays (as the title will soon reflect).

This thread lacks organization, plain and simple. I'll try to put out a list each weekend in a format this is sorted by soonest expected action dates or news. I will need your help. There are a lot of these stocks and anyone who has a familiarity with any pharma that has potential will certainly be welcomed here. My forum signature will also contain a link to a post that will be constantly updated with stocks and dates. I believe that with sound money and risk management, profit can be made on these plays even considering the big losers. I'll address my individual strategy, too.

That's all for now; I've quite a lot to do.