lazycatcat
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Are DNDN's hits small molecule drug or large molecule drug under bio production path like DNA and Amagen ?
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精华 苦辣酸甜难书尽，成败得失笑谈中
- 主题发起人 加京游子
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Are DNDN's hits small molecule drug or large molecule drug under bio production path like DNA and Amagen ?
Provenge is first in class immunotherapy, a cancer treatment paradigm change. Conditional on Provenge's approval, this revolutionary line of treatments will take over the oncology and part of urology markets sooner or later, wherein Provenge and Nuevenge will be the SOC against which any forthcoming new treatment will be evaluated. Stimuvax works more or less in the same MOA. Depending on the NSCLC trial results, Stimuvax may join this family of treatments. As for breast cancer, Nuevenge and Stimuvax may become competitors but the market is so huge that competition is really not a concern at all. The issue is production capacity to meet demand. Nuevenge was also indicated for ovarian cancer in the Phase I trial. The September 24 Analyst Day will definitely unveil DNDN's plans going forward and a lot more can be learned by then. If the expected ROW partnership is announced before or on September 24, watch DNDN to soar. Also, the 360-event analysis results may be announced on or before September 24, which are expected to be better than the 304-event results released at the UAU in April. The 304-event results are what the aBLA will be based on but the 360-event results will be submitted along with the aBLA for sensitivity and robustness analysis.
DNDN, ARNA and DVAX are all expected to come out with huge news this month. This could very well be a monster month for me. I would pray for positive BLOSSOM results to come as soon as possible so that I can cash in to significantly add DNDN and DVAX. I am fully loaded with ARNA and won't add. Although I expect BLOSSOM to hit, this is far away from certainty and my line of position is highly speculative. I put in about 10% for this venture, going for a kill or getting killed. For now, I can only patiently wait.
Disclaimer: what I post hereby is my own personal DD. Any reader who takes actions as a result of my posting, while I wish you the very best of lucks, is fully responsible for his/her own actions. It is your money and only you can safeguard it.
Zack's Analysis on ARNA and Lorcaserin
In my own view, this is a well-balanced analysis of the sector and Lorcaserin, unlike the fear-mongering, lie-telling CNBC and Street.com bashing. While both Qnexa and Contrave have reported severe safety issues, Pramlintide is about 2-3 years later. Keep it here for later reference.
------------------------------------------------------------------------
In our view, obesity remains the single largest opportunity for a new pharmaceutical product today. Roughly two-thirds of the U.S. population is overweight. The number is expected to grow to 75% by 2015. There is massive unmet medical need and clear pharmacoeconomic benefits to curtailing the problem.
According to the Journal of Health Affairs, obesity costs Americans $147 billion per year in total medical costs. This is 10% of all healthcare spending, and that number has doubled since 1998. Studies have shown that reducing body weight by as little as 5% has a meaningful impact on reducing these co-morbidities.
New Products Are Coming...
Several biotechnology companies are working on the next wave of obesity candidates. These include Arena's (NasdaqGM: ARNA - News) Lorcaserin, Vivus' (NasdaqGM: VVUS - News) Qnexa, Orexigen's (NasdaqGM: OREX - News) Contrave and Amylin's (NasdaqGS: AMLN - News) pramlintide.
Contrave has completed phase III trials and Orexigen's management is expected to file for approval in early 2010. Qnexa is currently in two phase III programs with an NDA expected around the middle of 2010. Amylin's pramlintide and metreleptin is currently in phase IIb. That gives Arena, with an NDA planned before the end of the year, the first-mover advantage.
Safety Is Key Determinant...
Analysis for Contrave looks similar to lorcaserin in terms of efficacy. Both products offered around 17 - 18 lbs of weight loss after one year of treatment. Vivus' Qnexa, which is a combination of phentermine and topiramate, offered up around 20 lbs of weigh loss after only six months.
Physicians' surveys have clearly showed that safety is the paramount concern. And, with the significant prescriber interest in reducing co-morbidities, tolerability and abuse potential are also high on the list of what makes an overall effective drug for obese patients. Physicians will want to prescribe a drug that they feel has excellent safety and tolerability, with a very good chance in helping the patient lose at least 5% body weight. We are starting to feel more and more like that drug is lorcaserin.
What's Next For Arena?...
The biggest near-term catalyst for Arena is the release of the phase III BLOSSOM data in September 2009. From this program, we will look to confirm the efficacy and safety demonstrated in BLOOM, and finalize the NDA package. Data from the ongoing BLOOM-DM program will be filed as a supplement to the NDA in 2010.
There are several scenarios that could play out in 2010. We expect Arena to file for approval in December 2009, putting the FDA action date in October 2010. Depending on the time of the BLOOM-DM sNDA, the FDA will include the diabetes language in the label in October, approve the drug in October and review the -DM data separately, or delay approval in October while it reviews the full application.
The FDA has not met many PDUFA action dates for NCEs over the past few quarters. Plus, the agency has been very tough on new "neuro-physical" drugs for things like obesity, neuropathic pain and fibromyalgia in the past. So we believe the third scenario is the most likely, meaning a final lorcaserin approval will come in early 2011.
Data from BLOSSOM will most likely provide a small pop to the shares. However, the best chance for a meaningful run in the stock is through the signing of a commercialization partnership. We think this will take place around the middle of 2010 after all three firms -- Arena, Orexigen, and Vivus -- have filed for approval of their respective drugs and potential partners can evenly weight the aspects of each application.
In my own view, this is a well-balanced analysis of the sector and Lorcaserin, unlike the fear-mongering, lie-telling CNBC and Street.com bashing. While both Qnexa and Contrave have reported severe safety issues, Pramlintide is about 2-3 years later. Keep it here for later reference.
------------------------------------------------------------------------
In our view, obesity remains the single largest opportunity for a new pharmaceutical product today. Roughly two-thirds of the U.S. population is overweight. The number is expected to grow to 75% by 2015. There is massive unmet medical need and clear pharmacoeconomic benefits to curtailing the problem.
According to the Journal of Health Affairs, obesity costs Americans $147 billion per year in total medical costs. This is 10% of all healthcare spending, and that number has doubled since 1998. Studies have shown that reducing body weight by as little as 5% has a meaningful impact on reducing these co-morbidities.
New Products Are Coming...
Several biotechnology companies are working on the next wave of obesity candidates. These include Arena's (NasdaqGM: ARNA - News) Lorcaserin, Vivus' (NasdaqGM: VVUS - News) Qnexa, Orexigen's (NasdaqGM: OREX - News) Contrave and Amylin's (NasdaqGS: AMLN - News) pramlintide.
Contrave has completed phase III trials and Orexigen's management is expected to file for approval in early 2010. Qnexa is currently in two phase III programs with an NDA expected around the middle of 2010. Amylin's pramlintide and metreleptin is currently in phase IIb. That gives Arena, with an NDA planned before the end of the year, the first-mover advantage.
Safety Is Key Determinant...
Analysis for Contrave looks similar to lorcaserin in terms of efficacy. Both products offered around 17 - 18 lbs of weight loss after one year of treatment. Vivus' Qnexa, which is a combination of phentermine and topiramate, offered up around 20 lbs of weigh loss after only six months.
Physicians' surveys have clearly showed that safety is the paramount concern. And, with the significant prescriber interest in reducing co-morbidities, tolerability and abuse potential are also high on the list of what makes an overall effective drug for obese patients. Physicians will want to prescribe a drug that they feel has excellent safety and tolerability, with a very good chance in helping the patient lose at least 5% body weight. We are starting to feel more and more like that drug is lorcaserin.
What's Next For Arena?...
The biggest near-term catalyst for Arena is the release of the phase III BLOSSOM data in September 2009. From this program, we will look to confirm the efficacy and safety demonstrated in BLOOM, and finalize the NDA package. Data from the ongoing BLOOM-DM program will be filed as a supplement to the NDA in 2010.
There are several scenarios that could play out in 2010. We expect Arena to file for approval in December 2009, putting the FDA action date in October 2010. Depending on the time of the BLOOM-DM sNDA, the FDA will include the diabetes language in the label in October, approve the drug in October and review the -DM data separately, or delay approval in October while it reviews the full application.
The FDA has not met many PDUFA action dates for NCEs over the past few quarters. Plus, the agency has been very tough on new "neuro-physical" drugs for things like obesity, neuropathic pain and fibromyalgia in the past. So we believe the third scenario is the most likely, meaning a final lorcaserin approval will come in early 2011.
Data from BLOSSOM will most likely provide a small pop to the shares. However, the best chance for a meaningful run in the stock is through the signing of a commercialization partnership. We think this will take place around the middle of 2010 after all three firms -- Arena, Orexigen, and Vivus -- have filed for approval of their respective drugs and potential partners can evenly weight the aspects of each application.
lazycatcat
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Thanks for sharing information on DNDN, DVAX and ARNA. From purely financing point of view, ARNA's short-term upside is probably capped by the recent convertible deal.
I don't like convertible deal like that because it provides opportunities for manipulation. If ARNA rise to $10 per share, actual appreciation is actually 300% versus 200% on purely per share basis. It might be worth considering to cap gain at $10 or $12.50 by selling calls.
DNDN's recent common share deal shows confidence by the market at $20 per share. There are about $80 M convertible debt on its book and I didn't dig into it as it seems to be done earlier.
I don't know how to play these three companies with downside protection....The amount of capital to be lost in options is low to my tolerance. So, really don't know how to play ...
I don't like convertible deal like that because it provides opportunities for manipulation. If ARNA rise to $10 per share, actual appreciation is actually 300% versus 200% on purely per share basis. It might be worth considering to cap gain at $10 or $12.50 by selling calls.
DNDN's recent common share deal shows confidence by the market at $20 per share. There are about $80 M convertible debt on its book and I didn't dig into it as it seems to be done earlier.
I don't know how to play these three companies with downside protection....The amount of capital to be lost in options is low to my tolerance. So, really don't know how to play ...
Thanks for sharing information on DNDN, DVAX and ARNA. From purely financing point of view, ARNA's short-term upside is probably capped by the recent convertible deal.
I don't like convertible deal like that because it provides opportunities for manipulation. If ARNA rise to $10 per share, actual appreciation is actually 300% versus 200% on purely per share basis. It might be worth considering to cap gain at $10 or $12.50 by selling calls.
DNDN's recent common share deal shows confidence by the market at $20 per share. There are about $80 M convertible debt on its book and I didn't dig into it as it seems to be done earlier.
I don't know how to play these three companies with downside protection....The amount of capital to be lost in options is low to my tolerance. So, really don't know how to play ...
Let me give you one advice if I may: play with what you can afford and are willing to lose. There is no free lunch in the world. One gets what one pays for. High returns are usually, if not always, associated with high risk. My capital base is such that I am fully prepared to get killed in order to go for a killing. Let me give you a Blackjack analogy: you see the card in the hole is a 5 and your hand is soft 18. How do you play your hand? Some people pass, others double down, and I belong to the latter.
Manipulation is a fact of life in Wall Street, particularly so in the developmental-stage biotech space. Big boys do get badly burned occasionally. Via 9902b data, DNDN sticked it up their rear and deep. Hopefully, ARNA will do the same via a BLOSSOM clear hit.
Attaching a numeric expectation based on traditional valuation models to a binary event is meaningless. TA does not apply in this kind of events either. Trial results trump everything else, manipulation or otherwise. Manipulation from the short side can only add fuel to the fire in case of good data.
lazycatcat
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Thanks for your advice. You courage and conviction on what you believe is marvelous. Someday I think we can team up to do real elephant hunting. I am sure there will be a lot of opportunities in the next pre-bull and bull market runs.
I will be an observer on the three bio's this time. It is fun to watch as well. At this point, the big guys have positioned themselves well and I may be like a sparrow flying into a badminton court if I participate now.
October will be an interesting month and we may find something ...
I will be an observer on the three bio's this time. It is fun to watch as well. At this point, the big guys have positioned themselves well and I may be like a sparrow flying into a badminton court if I participate now.
October will be an interesting month and we may find something ...
Thanks for your advice. You courage and conviction on what you believe is marvelous. Someday I think we can team up to do real elephant hunting. I am sure there will be a lot of opportunities in the next pre-bull and bull market runs.
I will be an observer on the three bio's this time. It is fun to watch as well. At this point, the big guys have positioned themselves well and I may be like a sparrow flying into a badminton court if I participate now.
October will be an interesting month and we may find something ...
Yes, being a diligent student of the market and learning to play the game is the only smart thing to do. Do not chase any stock, on the long side or short. Let it go if you think it has got away from you. Case in point: my missing AIG from both sides lately. I had the idea of shorting it right at the reverse split (this was just an instinct, possibly formed in my brains from watching so many RS failures before) but did not dive in because I wanted Mr. Market to test if my idea was correct . It did move in the way as I expected. Then the banning of naked short in combination of a surprise profit sent it rocheting up. I had the idea to get in when the move up just started but the signal was not strong enough for me to take a position. I kept watching like a hawk. Then I had to go to a meeting and it shot up in the course of half a day and got out of my comfort zone. So, the only thing left for me was to closely watch for a possible shot opportunity again. When I finally felt it was time to dive in for puts, Tradefreedom's system broke down and my buy order was not executed. No trade in AIG either way. I move on and do not dwell on missing opportunities. AIG comes and goes. Other stocks will come and go. September comes and goes. October will come and go. 2009 comes and goes. 2010 will come and go. Mr. Market will be there day in and day out, full of opportunities. Be patient and you will find them. My three bio combo may or may not run. The only one I have fresh working capital in is ARNA. I am playing the other two with the house money and not worrying about losing the money I did not have to begin with anyway. Do be prepared for not only the unexpected but also the unexpectable. Mr. market is played by human beings and human beings are more often than not unpredictable.
lazycatcat
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Based on DD on ARNA, I would sell Oct $2.5 put currently priced at $0.40. Cash per share should be at $1.7 now and maybe $1.5 at end of Q3. The BLOSSOM results at least would be neutral I guess. So, the chance to earn $0.40 and lose $0.40 is better than 50.
Just raise this as an example on my type of character in doing things. In the bio field, there might be such chances to write puts ... Never thought about this before. Your bio study helped ...
Just raise this as an example on my type of character in doing things. In the bio field, there might be such chances to write puts ... Never thought about this before. Your bio study helped ...
Based on DD on ARNA, I would sell Oct $2.5 put currently priced at $0.40. Cash per share should be at $1.7 now and maybe $1.5 at end of Q3. The BLOSSOM results at least would be neutral I guess. So, the chance to earn $0.40 and lose $0.40 is better than 50.
Just raise this as an example on my type of character in doing things. In the bio field, there might be such chances to write puts ... Never thought about this before. Your bio study helped ...
IMO, writing Oct. 2.5 puts is very close to making free cash provided your capital will be tied up until expiration. But at the 2.5 strike, capital requirement is really minimal. The risk of losing money by writing the 2.5 puts is very low. If ARNA does fall hard, you won't be under water unless it goes below 2.1. I would really love to be put shares at that kind of price, haha. Options are not marginable and I am fully loaded, I would otherwise write some Oct. 4 puts to reduce my calls cost base. But again, I think BLOSSOM has a much better probability of hitting than missing and as such, longing calls is more profitable than writing puts. Of course, the associated risks with longing calls are far greater. As I am bullish on BLOSSOM, I will not consider any spread play by writing higher-strike calls. Like I have stated before, I simply have no idea how the market will react and what the upside potential is should BLOSSOM hit. I do not want to limit growth potentials. Because of lack of conviction before, I missed out a boatload with GNW, BCRX and NVAX. I made the right picks and entries but failed to follow through these operations with conviction. If one does not gain or even suffers losses from the operations, right picks are no good anyway.
We are distinct individuals with different perspectives. Act in the way you feel prudent.
This thread was started with the premise that I will use it to record my transactions along with my DD. Then people like you came along and we started discussions and exchange of ideas. It should be clear to all that I am not hereby spamming any stock I own. Rather, I will be very happy if readers can benefit from my postings by taking them as leads and taking actions after their own DD.
lazycatcat
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I hope I am not hijacking your account of your experiences. If I am, we can either open up a new thread or we can discuss via emails.
I think we should focus on meaningful discussions like DD and ignore the rest. To many people, investment is very personal, ego, envy, self-delusion etc etc. I was amazed how people distorted Buffett's recent purchases of GS, GE, CDS and S&P 500 derivatives just to fit what they want to say. They don't bother to read Buffett's letters and details of these deals but just want to say something.
Also, Fairfax looked like a bunch of idiots back in 2003 thinking there was 1/50 to 1/100 that a depression like event would occur. Plus, they were losing money in their hedging till 2008.
Good investors or hairy speculators are always few. Otherwise, how can they become rich by just playing seemingly zero-sum game ?
ARNA shows how DD could generate different type of speculation opportunities. I won't say $2.5 put is riskless but the odds might be greater than 50. So, if one does a string of them, the overall rate of success might be high.
On writing put options (and overall option pricing), I do have a question to you since you have a PhD in economics.
In general, option price is derived from Black-Scholes model. By using this model, we can derive ARNA $2.5 Oct put pricing for instance. If the market price is equivalent to this model price, we may say that the market is using a mechanical way to get the price.
If this is true, then we may have an advantage by considering special cases like BLOSSOM etc.
Do you agree with this line of thinking ? How to easily derive Black-Schole price in practice ? I mean a B-S calculator sort of things ...
I think we should focus on meaningful discussions like DD and ignore the rest. To many people, investment is very personal, ego, envy, self-delusion etc etc. I was amazed how people distorted Buffett's recent purchases of GS, GE, CDS and S&P 500 derivatives just to fit what they want to say. They don't bother to read Buffett's letters and details of these deals but just want to say something.
Also, Fairfax looked like a bunch of idiots back in 2003 thinking there was 1/50 to 1/100 that a depression like event would occur. Plus, they were losing money in their hedging till 2008.
Good investors or hairy speculators are always few. Otherwise, how can they become rich by just playing seemingly zero-sum game ?
ARNA shows how DD could generate different type of speculation opportunities. I won't say $2.5 put is riskless but the odds might be greater than 50. So, if one does a string of them, the overall rate of success might be high.
On writing put options (and overall option pricing), I do have a question to you since you have a PhD in economics.
In general, option price is derived from Black-Scholes model. By using this model, we can derive ARNA $2.5 Oct put pricing for instance. If the market price is equivalent to this model price, we may say that the market is using a mechanical way to get the price.
If this is true, then we may have an advantage by considering special cases like BLOSSOM etc.
Do you agree with this line of thinking ? How to easily derive Black-Schole price in practice ? I mean a B-S calculator sort of things ...
lazycatcat
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You might be following but tomorrow may be interesting for ARNA. Another company in the same sector is announcing something that might be significant....
Have I chosen the wrong horse to ride? how high can ARNA go should BLOSSOM hit?
VVUS released its two pivotal trial results for Qnexa at 6am and will host a conference call at 8am. The stock gained over 10% yesterday and more at AH trading after the pre-announcement yesterday at 4:02pm. I need the bottom line data to make a judgement. The top line data look good and the stock breaks out in light PM trading. If the safety and tolerability profile is not good and the stock rochets up on top line data, I will short it. I would otherwise let it go.
Qnexa is a cocktail of two drugs that were not originally designed for weight loss. The weight loss function is a side effect, like Viagra was originally designed to treat heart disease. OREX' Contrave was not originally designed for weight loss either. Of the three main weight loss treatments currently in development, only ARNA's Lorcaserin is originally designed for weight loss. ARNA spent over 12 years and over $1B on this. Earlier trial results indicate efficacy is not the problem with Qnexa and Contrave but the safety and tolerability profiles. Lorcaserin OTHH demonstrates a highly impressive safety and tolerability profile.
Yes, I follow sister stocks like a hawk, especially during this binary event period. Only time can answer the first question posted in my headline. For the second question, only Mr. Market has the answer but market reactions to VVUS should give some hint.
VVUS released its two pivotal trial results for Qnexa at 6am and will host a conference call at 8am. The stock gained over 10% yesterday and more at AH trading after the pre-announcement yesterday at 4:02pm. I need the bottom line data to make a judgement. The top line data look good and the stock breaks out in light PM trading. If the safety and tolerability profile is not good and the stock rochets up on top line data, I will short it. I would otherwise let it go.
Qnexa is a cocktail of two drugs that were not originally designed for weight loss. The weight loss function is a side effect, like Viagra was originally designed to treat heart disease. OREX' Contrave was not originally designed for weight loss either. Of the three main weight loss treatments currently in development, only ARNA's Lorcaserin is originally designed for weight loss. ARNA spent over 12 years and over $1B on this. Earlier trial results indicate efficacy is not the problem with Qnexa and Contrave but the safety and tolerability profiles. Lorcaserin OTHH demonstrates a highly impressive safety and tolerability profile.
Yes, I follow sister stocks like a hawk, especially during this binary event period. Only time can answer the first question posted in my headline. For the second question, only Mr. Market has the answer but market reactions to VVUS should give some hint.
lazycatcat
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Jia
Can you give some details on OREX and ARNA versus VVUS in terms of their drug profile ? Efficiency and safety. It seems VVUS is quite safe and provides the biggest weight reduction.
Any scheduled announcemnt by OREX ?
I can contribute from financing point of view. VVUS had a straight share offer early 2008. I will dig a bit more.
I must say bio area is fun but needs better weapons/timing to catch fun.
Any other bio you are following ?
Can you give some details on OREX and ARNA versus VVUS in terms of their drug profile ? Efficiency and safety. It seems VVUS is quite safe and provides the biggest weight reduction.
Any scheduled announcemnt by OREX ?
I can contribute from financing point of view. VVUS had a straight share offer early 2008. I will dig a bit more.
I must say bio area is fun but needs better weapons/timing to catch fun.
Any other bio you are following ?
lazycatcat
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There doesn't seem to be pending news from OREX, except for the presentation on Sept. 15th. OREX also had a straight common share offering at $7.5 in July.
ARNA is the only one among the three that did a major convertible offering. Based on today's VVUS valuation, the convertibles probably will cap ARNA potential gains....
On the other hand, small probability event can always happen ...
ARNA is the only one among the three that did a major convertible offering. Based on today's VVUS valuation, the convertibles probably will cap ARNA potential gains....
On the other hand, small probability event can always happen ...
