精华 苦辣酸甜难书尽,成败得失笑谈中

It is a sad story for patients and shareholders! A highly anticipated pivotal Phase III clinical trial failed to meet the primary end point. Panic takes over the investment community, shareholders killed for the exit, and the stock tanked by 66% to closed at multi-year low. My accounts suffered paper losses in the thousands upon thousands of dollars. Rather than cutting the loss and moving on, I chose to increase my share ownership by 500%+ on the conviction that cooler heads will ultimately prevail, fully ready for another block of buy when the dust settles. The stock is priced very much like out-of-money calls sans the expiry date and I expect options-type returns up the road. Good move or bad, time will judge.

It has around $0.45 cash per share. What do you think is the next significant events ?

On VVUS, the options are really too expensive either way. That is why I synthesized this idea.....
 
On VVUS, there is still a possibility of repeating DNDN's down fall in first FDA approval event. If FDA rejects its obesity drug, I guess VVUS will tank. I haven't followed the second drug but assume it is less significant...
 
Bio companies seem to be resilient in coming back. It is a good idea to build positions when they are substantially down ...
 
No work, no market, it is DD time …

[FONT=&quot]Putting vague ideas picked up from here and there down in writing solidifies plans and strategies going forward.[/FONT]

[FONT=&quot]1) [/FONT][FONT=&quot]The weight management trio[/FONT]

[FONT=&quot]OREX is out of the picture. The only regret is that I did not buy some puts after it more than tripled and crossed 5, riding the VVUS AdComm tail wind. Leaving it alone is the only right move to make.[/FONT]

[FONT=&quot]That leaves VVUS and ARNA to ponder. VVUS has Qnexa AdComm in the bag and waiting for PDUFA decision for Qnexa on April 17 and Avanafil on April 29. Approval for both is widely expected. IMHO, the Qnexa approval will come down with a post-approval CVOT and a highly restrictive label/REMS. As such, the pressing question is valuation. Has the present pps baked in such a conditional approval? Differences in opinions are so wide-spread that one can drive a truck through. Two polar scenarios cross mind pertaining to Qnexa --- a) the pps soars upon approval as many bull-side analysts touted (JPM tops the list); b) approval is baked in and the post-approval pps levels off or retraces mildly heading into April 29 for the Avanafil ruling. Given no firm conviction on the direction, I will sit on the fence for the Qnexa PDUFA as I did for the AdComm. Should Scenario A materialize, VVUS becomes a putting target but I will wait after the Avanafil ruling. If Scenario B follows through, I will play May calls for the Avanafil PDUFA. I plan to switch sides and putting into Qnexa launch. VVUS is a long-term putting target anyway for 5 considerations: a) the pretty much certainty of a CVOT study will cost a monstrous amount of money; b) the REMS will delay launch and labelling limit target population and hence sales; c) while the market potential is still humongous, Qnexa can’t be taken on a long-term basis given the duration limit of source drugs; d) while the CEO is a great salesman, LeLand and top executives are an extremely greedy bunch, cleaning out of positions at every top with insider information, worse than Mitch Gold of DNDN; and e) ambulance chasers will surely run wild should a few CV events/birth defects occur, which is highly expected given the wide use.[/FONT]

[FONT=&quot]Having done all research DD that can possibly be done, my serious long position in ARNA has been taken with a conviction. It is up to fate now. Continuous trading DD dictates that I adjust position at the margin. This week, I bought back 1/2 sold April 3P to release some locked in capital and added May calls. Expected two immediate catalysts: a) VVUS Qnexa PDUFA on April 17 --- ARNA should enjoy a good run upon an approval (a rising tide lifts all boats) and will surely get a short-lived hit if VVUS is handed down a disapproval but should recover quickly as we are down to a one-horse race. This is one potential chance for a bear raid and need to be guarded against; and b) AdComm on May 10 --- trading halted, briefing documents should be publicly released on the 7th or 8th, another potential chance for a bear raid. How things proceed post May 10 is entirely conditional on the AdComm result. Assuming a positive Adcomm result, whether or not the PDUFA on June 27 is tradable depends a lot on the then valuation. Should the FDA issues another CRL, miserable suffering is the only end result awaiting ARNA shareholders post June 27. But that may not be the end of the ARNA world. EMA’s MAA ruling can be expected before the year end --- speculation alone in the fall will likely pull ARNA out of the post-CRL wreckage.[/FONT]

[FONT=&quot]Being badly burnt twice by ARNA (2009 Blossom data release and 2010 AdComm), my conviction in the science has not wavered and hence the bet on the table now. As far as trading goes, I plan to lighten up the load pre-AdComm rather than hedging with puts that increase cost basis. Hope there will be a good selling opportunity in the near future sparked by the Qnexa approval and AdComm speculation.[/FONT]

2) The advanced colorectal cancer duo

Bad news hit the wire for KERX and AEZS Monday --- the X-pect trial failed to meet the primary end point mainly due to placebo patients living significantly longer than expected with earlier trial results/literature. When it rains, it pours down. WS was not satisfied with a single-day 67% loss caused by the failed trial, both stocks suffered multiple downgrades Tuesday, and AEZS was down another 10% intra-day. Was this killing for the exit panic overdone? Yes, way overdone, IMHO.

I have never owned KERX. With no intent to initiate a position there now, let me concentrate on AEZS. The duo are tied at the biblical cord by Perifosine --- KERX licensed its right to North America and foots all development/marketing costs. While the Phase 3 trial is ongoing for multiple myeloma, KERX CEO stated at the CC that given this failure, recruitment is expected to be more difficult than before. So, let me write off Perifosine for North America. Actually, let’s completely write it off although Phase 3 trials for advanced colorectal cancer are ongoing in Japan and South Korea by AEZS’s respective partner.

So, what is left with AEZS/AEZ.TO?
• Marketed Cetrotide. Its world-wide right was sold but manufacturing charges and royalties still produce a stream of revenues that supports pipeline developments.
• AEZS 130. A registration trial was successfully completed last year for human growth hormone difficiency test. An NDA for this indication is expected to be filed shortly. Phase 2 trials for cancer cachexia are under way.
• AEZS 108. Multiple Phase 2 trials are under way for ovarian, bladder, endometrial, and prostate cancer.
• Pre-clinical trials for a good number of pipeline candidates.

Are all of these worth a laughable quarter per share? Crazy or what! Value? Show me any better deal out there, please!

Trading wise, I owned quite a few shares before Monday (since last fall) and my paper loss is naturally rather sizable. Seeing the bad news, I bought a block at 8:01am Monday (iTrade isn't opend for PM trading until 8am), which turned out to be a very bad buy as that was the PM peak (my propensity of buying at the high is very high, sigh), about 30% higher than what could be had during regular trading. I got another block filled during the regular session, planning to buy another block either Wed. or yesterday when the dust finally settles but failed at that plan as I was more than occupied. May still get that last block comes Monday.

At the average cost basis, I am still severely under water by yesterday’s close but expect this paper loss to disappear in the not so distant future. It goes without saying that an important trial failure results in a sharp fall in pps for any baby biotech. But the degree of this panic selling and loss surprised the hell out of me --- there is simply no way Perifosine accounted for 70% of AEZS valuation despite its importance. What is unduly lost will ultimately be gained back. As much as I would kill to see, a fast bounce back may not materialize but patience will surely be rewarded handsomely in this grossly undervalued stock.

3) The Phase 3 pivotal trial final data readout duo

• ONTY (formerly BIOM). On and off with BIOM since my DNDN time. Made a killing selling Feb. puts. Heading into the final days of the second interim peek, my expectation was consistently a “continue” as the bar for passing the interim is set unusually high for most companies don’t want to significantly reduce the chance of success at the final data readout by consuming a big alpha spend. But the appeal of hitting big got the better of me and my March 15C expired worthless. Expecting a fall to around 4 and a secondary offering, I pinpoint myself to an entry after the secondary is closed. All materialized and got 1/2 position at 20 cents above what the new institutional holders paid for. Retailers can’t enjoy institutional discount anyway but I am still targeting to go for the institutional discount ($4 shares or below) to fill the remaining 1/2 position by selling near-term puts.

With the new capital raise completed, what may come down the pipe then?
 Stimuvax. Final data readout for lung cancer isn’t expected until year end or early next year. The water on that front may remain still until then. However, with the numerous trials being run by Merck Germany, violent waves may still be made in that pond.
 PX-866. Phase 2 trial results are expected in the near future.
 ONT-10. An improved version or second-generation of Stimuvax. Phase 1 trial was initiated a while back.

Comes fall, speculation on the lung cancer trial will more likely than not heat up and carry ONTY to much higher levels.

• CLSN. Have been in since early last year. Got hit pretty badly when the interim result was a “continue”. Rebought for a possible 2nd interim peek, which was shot down by the FDA and the pps hovers around 1.8 now. The flagship candidate is ThermoDox. This is a platform of drug delivery rather than a single agent. The key indication is for primary liver cancer and everything evolves around the Heat Trial, whose final data readout is expected by year end or early next year. Other trials (e.g., chest-wall breast cancer, colorectal liver cancer metastases) won’t be worth much if Heat fails. May be dead money until the fall but will 2X holding if it ever visits the low 1.6s.

4) The lonely junior uranium miner, DNN/DML.TO

Got in after the crash post the Japanese Earthquake, only to watch the pps dipping down further and further upon Germany's declaration of planning to cease the use of nuke power by 2020 and the summer/fall market correction. Thanks to a good run earlier in the year, an exit was made and a good-percentage profit was booked. The commodity spot price and miners, by implication, may have run a little ahead of themselves. So, the correction/consolidation has been going on for a good month now. There are words out there that Japan may put reactors back online and Gernany may reverse the last-year-declared plan soon. Further, China and India are planning on more reactor buildups. Occasional accidents aside, nuke power remains the most cost effective and environmentally friendly source of power. It has been here long ago and is staying. If anything, the demand for uranium will gradually increase and a shortage of supply can be expected in the year of 2014 if not in 2013. Can DNN/DML.TO go lower, sure, anything is possible on WS. But at 1.5, the downside risk is highly limited. I am planning for a re-entry within the next couple of days.

5) The comeback alert duo

• CBLI. Enjoyed an explosion early last year on BARDA funding speculation and then, ran wild on the Japanese Earthquake for a couple of days. It has been all downhill from there, with intermittent spikes on news. After a good run to 4 not long ago, it started tanking Wed. when BARDA rejected its white paper for development funding. The flagship candidate is CBLB 502, intended for acute radiation syndrome (ARS). It addition, it has potentials in reducing side effects of cancer chemotherapy (as an adjuvant) and anti-cancer functions. The company pursues CBLB 502 on both ARS countermeasure and oncology fronts. Thus far, BARDA and DOD funded most of the development. DOD has a procurement contract of $30M in place conditional on the FDA approval based on the animal model. Phase 1 trial for head and neck cancer has been initiated. There are other activities in Russia. The company is meeting with the FDA on the animal model and human safety pathway this month or May.

• CHTP. The pps tanked all the way to multi-year low of 2.18 from low 5s in a matter of a couple of days when the company released briefing documents in advance (very rarely done), recovered somewhat heading into the AdComm and the positive AdComm result made it an instant 70% gainer, only to watch it dipping away heading into the PDUFA. I swapped shares for out-of-money calls on the decision day to reduce exposure. Upon the CRL, the pps tanked but not to the extent at which I was comfortable with an entry. Then a 10% daily haircut persisted for quite a few days and reached a multi-year low of 2.01 intraday yesterday. The drug has been used in Japan for many years and has an orphan designation. The CRL doesn’t sound a hard outright rejection. If Trial 305 provides positive results, the drug may be approved within the year. The company is meeting with the FDA in May.

Whether or not these selloffs were overdone is hard to judge at the moment. Bottom-fishing attempts can run the risk of catching falling knifes. I will just keep an eye wide open and move when dust settles. May very well miss the bottom. Should that be the case. so be it. It is better with missing than being wrong.
 
Bio companies seem to be resilient in coming back. It is a good idea to build positions when they are substantially down ...

1) It is also a great idea to buy APPL at 11 and hold until now! The same can be said about buying BIDU at 3 (split-adjusted)! By the same logic, it was a great idea to buy microsoft in the quarter when it was first IPOed and sell in the 120's in 2001. If memory serves me correctly, SINA dipped below .25 (non-split-adjusted if SINA ever executed any split, excuse me for the ignorance --- I took my eyes off that many years ago) and was delisted at one point. Was that a great entry point, wasn't it? When I posted about DVAX around .7 a good number of years back, you said you want in at .2, .3 below cash. I imagine you are a multi-billionnaire now with all your wished-for trades materializing. Everyone is the best Monday morning quarterback.

2) Picking selected battles to fight is paramount, being a moon-lighter with limited knowledge and working capital. A good number of baby bios go belly up at any moment of the day. Said generalization is as good as what the dumptruck picks up from my laneway every Friday!

3) I am not posting for entertainment. Going forward, please execuse me for not responding to posts that don't contribute to sharing and/or discussion (positive or negative).
 
Options strategies for ANRA's May 10 AdComm

I am discussing said strategies with a poster on the YMB. Below is the conversation.

I currently have 1500 May 19 $7 calls. I am self taught on options but quite frankly, I don't really understand the details as they get very confusing with Volatility and the like. I just want to acquire as many options as possible with the $ I have available irrespective of the strike price and within the time frame I have selected, in this case May. I only purchase options when I think I have found a Winner like ARNA. My average cost is $0.3347 for the 1500 $7 calls for May.

I believe the adcom will approve May 10 so with that assumption, is my current strategy owning the 1500 calls a practical strategy? I do not do puts. My main objective is to maximize total return and to have a sell date no later than May 16 when I will reinvest the money back into ARNA.

Please offer any serious trading ideas for call (long) option strategy's I should be thinking about with the scenario above.

Thanks

C. Brown
Minnesota

My reply is given below.

Gosh! You and I collectively own the overwheming majority of May 7C. I was a bit late getting in and paid .39 on average after selling my July 1C for a double and March 2C for a triple. I was actually looking for .2-.25 May calls for a commitment of 20K regardless of the strike price but none was available at the time I was shopping. I did not have the patience to wait and always buy at the ask. I have added some since the first big buy. I also own a good number of May 4C and 6C. I plan to sell those when the pps hits 5 and buy May 5P to have a straddle heading into the AdComm. Although I am highly confident of a positive AdComm result and a pps north of 10 comes May 11 and we can sell May 7C for 3+, it is not a bad idea to have the 5P as insuarance. Straddle is the best strategy going into a binary event which provides downside protection while upside potentials are not capped, conditional on being bullish. Any collar strategy like the one proposed by the SA author is down right human waste and should be treated as such. This is a high-risk high-reward play. If one can't stand the heat, one should get out of the kitchen, as simple as that. Let go and buy some treasurys/GICs if 2-3% per annum is what one is after. This is self-taught after paying unthinkably high tuition fees for the DNDN rejection in 2007 after a positive AdComm vote and the ARNA 2010 disaster (near a financial ruin). I may also simply scale back my exposure by cashing out some May 7C chips. I want to head into this AdComm with house money only with maximizing potential profits.

Best of lucks, my dear May 7C co-holder! Let's meet at this year's ASM and talk. My drinks are on you if we manage to sell our May 7C for 3+ because you own more than I do. I plan to own ARNA for many years to come but that is conditional on getting the FDA nod on or before June 27. Anyway, first thing first, let's get the AdComm in the bag on May 10 --- I want a vote no worse than 16:6. Anything better is icing on the cake. I am counting two No already --- Colman and Kaul.
 
Calling for AEZS top executives to react and act proactively and swiftly!

The investing community was simply blindsided Monday. There was nothing this heavy bagholder could do but adding heavily, after licking deep wounds. Six long days have elapsed. Conspiracy theories abound now. Though not believing in those, this heavy bagholder do have a series of questions as this futility just doesn't smell right!

1) How could both arms of patients suddenly have identical median survivals, so much out of line with earlier trial results and literature? Did the IDMB not run an interim peek just last August and gave X-pect a "continue"? The trial design is inevitably called into questions!

2) Who decided to increase placebo dosage from Phase 2 to Phase 3 and why?

3) Could it be possible that the labs screwed up and dosed placebo patients with treatment? Or data are entered and recorded wrongly?

4) When was the result known to the company? Why the hasty announcement of results without any data and no Q&A at the CC?

We investors feed the company and deserve nothing less than knowing the truth. We have been kept in the dark for way too long!

This heavy bagholder is calling for management to react and act proactively and swiftly!

1) Open up your fat wallet and put a fraction of the rich wages and bonuses you have collected from us investors for many years back into our company. I am sure each and every of you can afford a minimum of 100K shares. For god's sake, many retail investors own more than that.

2) Work with KERX to get the full story out swiftly! And decide the fate of the MM trial quickly. Cut loss if you have to.

3) KERX is simply a partner too small to handle the trials, pocket wise and experience wise. If they deccide to abondon ship for both CRC and MM, reclaim North American rights and work on better suitors. Go to court if that is what needed to get the rights back.

A heavy yet still faithful bagholder
 
If approved on June 27, ARNA will front run VVUS to market

VVUS Qnexa PDUFA date is extended by 3 months to July 17 for review of submitted REMS. IMHO, this is equivalent to an NDA modification and I view it as a hugely positive new development for ARNA heading into May 10/June 27. I will likely have to somewhat adjust my game plans now. It is significant for ARNA to change its status as a tag along to a front runner.

From where I stand, I sense the tone change in the FDA --- it wants to approve Qnexa but to be on the safe side, it requested an REMS before handing down a ruling. By the limited experience I have followed the FDA, this is the first time the agency reviews a modified NDA and extends the PDUFA date by only 3 months. For ARNA, this new development is better than Qnexa approval. Not to be a Monday morning quarterback, I for one did not take lightly the huge calls trades over the past few days. I added to my position after seeing those monstrous blocks of calls being scooped up like hot cakes. I am betting a huge volume day tomorrow with the pps closing significantly higher. I see VVUS profits rolling in and shorts running for cover, competing for an increasingly decreasing flow.

VVUS comes into play with this new development too --- a lot cheaper for an Avanafil trade.
 
What is the significance of this delay on VVUS ? In general, it probably is negative as FDA is not sure ...
 
What is the significance of this delay on VVUS ? In general, it probably is negative as FDA is not sure ...

再简短地回一帖!

我们老家拜师的规矩:择黄道吉日,备好菜、好酒、拜师帖、红包,行九叩头礼。
 
Tough questions on VVUS and ARNA

1) To put or not to put VVUS now? I have not seen any bio stock not going significantly lower with a PDUFA delay.

2) To sell or not to sell a portion of ARNA pre-AdComm? When and at what level? After playing second fidel for all these years, ARNA becomes the front runner all of a sudden. Finally, WS is served with a long-deserved wake-up call. If this is not a strong buy catalyst, I don't know what it is then or whether there is one. Is EMA acceptance of MAA filing enough to offset dilution and ARNA reclaims the 2010 pre-AdComm peak of $8? Once $5 crosses the tape, the hurdle for mutual fund entry is lifted. Will they step up to the plate? Will trading be steady or extremely volatile? I wish I had the crystal balls.

In addition to the huge volume trades of May 5C yesterday, a few notable 2013 LEAP trades caught my eyes:
1) 10C --- 1000@.56; 12.5C --- 522@.44
2) 10P --- 800@7.55; 12.5P --- 492@9.85
 
Gobbled up some more cheap ARNA shares in the PM ...

Thanks to the fraudulent AF and Street.com. Can't help. On leave today to watch this little addition to grow! Also get a buy order in to guard against the possibility of a bear raid at the open.
 
It was an all-out war in Arenaland today

I was wrong about ARNA trading today, dead wrong!

It is what it is. Logic often does not work in herd. I shall forgo analyzing or over-analyzing the rationale behind today's move. The horse is already dead, can't beat it any deader.

I was contemplating about adjusting my position at the margin and twitting my gameplan upon last night's Qnexa PDUFA delay. Heading into today's session, I was prepared for a bear raid, originally conceived for the Qnexa PDUFA ruling, which turned out to be a selloff. The ongoing battle challenged my resolution and conviction to react/act. I took up the task head on, called out reserve troops and sent them to the deadly frontline. Re-enforcement was all done today, not twitting at the margin as planned.

It was a sea of red out there today, and the day to be greedy!
 
Piper Jaffray, AF, SA ...

They are hired-guns and their hit pieces all serve one and only one purpose --- drive down the pps for their masters to cover amidst an increasingly decreasing float. They time well today: 1) broad markets tanked; 2) biotech got runover, especially speculative baby biotech; 3) Qnexa PDUFA was delayed. I feel sorry for those who follow these manipulation-minded fudsters blindly and lost their shares in the cheap. All they managed was a quarter, which I am highly confident we will gain back this week if not tomorrow.
 
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