AMLN
Ok, so now we've had two positive news releases by AMLN... One indicating that the LAR NDA was accepted by the FDA and the other that they've had some good results out of the Phase II obesity trial. I did not expect much out of the NDA press release as it was expected. The obesity Phase II trial results on the other hand should have yielded a better price movement. The study was sizable (608 patients) and the results were excellent, as a reference point, about twice as good as what ARNA got in their latest Phase III announcement. The result confirmed earlier Phase II trials the results of which can be found in one of my earlier post in a comparison chart with other competitors. What does this mean for my investment in AMLN, literally nothing, I am neither adding nor subtracting shares based on this and this is why.
- The obesity pipeline is still only in Phase II... And AMLN has had multiple phase II obesity trials..
- They have offered no guidance as to what is next
- Their obesity cocktail is an injectable. And AMLN's history with marketing injectables is very suspect
- Other competitors, although plagued by safety concerns, are further ahead and are not injectables.
- Obesity commercialization is far in the future... 2013?
- No partner yet. I don't feel that the obesity pipeline impact on PPS will be reflected until they find a partner. Wall street might then think they are serious and truly have something. AMLN management on its own has close to zero credibility left.
The near term drivers in this stock are still.
- FDA decision on ligaritude
- FDA decision on monotherapy for byetta and the bogus pancreatitis label update.
Obesity is not in play at this time for AMLN
ARNA
The stock to a tumble to $4 over the last couple of days after the announcement of the stock offering. This is fairly typical response whenever their is a dilutive stock offering. In general stock do recover once the shorts have taken their pound of flesh. I expect he same will happen with ARNA.
So in summary, ARNA is in play for obesity, AMLN is not yet in play....
Thursday, July 9, 2009
Friday, July 3, 2009
ELN heating up, AMLN should be heating up, DNDN, ARNA maintaining status quo
ELN
With the latest J&J cash infusion and partnership, ELN now has all the tools to succeed, money & strong pharma support / validation of its pipeline... Two clouds remain, the PML issue, although with no real news or development, continue to be used relentlessly by the short cabal to drive the PPS down every time a case is reported... I don't know how long this will be allowed to go on, as the FDA allows for 1/1000 case to occur and with all the reported case we are well below that rate. The second cloud is the management strength, let's hope they don't waste the new opportunity they've been given. The current stock price does not reflect the new found strength, as a lot of the risk has been removed from stock. I am looking for the low teens in the near future and selling puts to accumulate.
AMLN
What a disappointment this stock has been this second time around! Never, has a management team done so little with so much. They have money, an incredible pipeline, two first and best in class drugs and yet they don't succeed. The root of the problem is the management team and culture that has permeated this company since the beginning. They were essentially a good development team, then after their drugs got approved, essentially did not and still have not changed their mode of operation. They have not been able to successfully switch from being a development biotech to a pharma with products to sell. They have hired poorly and their current CEO is a big part of the problem.. He appears to be a hard worker, but exudes little confidence and is a horrible communicator... Anyway, enough ramblings... What to do?
I am staying put with my holdings, the upside is still great, but I probably will exit in the mid 20's if the pps gets there. The catalyst for a move up in the short terms are..
- A rejection of ligaritude ( a byetta competing drug ) by the FDA.. The FDA should reject or at minimum give them an approvable letter, but you will never know with the FDA as they are for the most part a captured and political agency. Note that Ligar has just been approved in Europe.
- Monotherapy for byetta. Its a decision that's more then 6 months behind schedule. I do not understand why the FDA has not responded yet, scratch that, I do understand, see above comments.
- Clarification of the Byetta label and the removal of the pancreatitis cloud from Byetta. Again, the FDA botched that one. They issued a safety warning for byetta for pancreatitis when the rate of occurrence is at worse equal to the diabetic population. The reality is even more perplexing, since byetta is prescribed to obese patient because of its weight loss proprety, the byetta population is even more prone to pancreatitis. So, the data seems to indicate that Byetta actually decreases the rate of pancreatitis... But go figure our FDA, they issue a warning, what a bunch of boobs!!!
But ultimately, its the role of management to play whatever game the FDA needs them to play to get these things done... And this management team just does not know how to play the game. The recent Icahn and eastbourne BOD wins, have yet to translate to any material changes .
A note of caution. A ligaritude approval could eviscerate the byetta scrips and send the PPS back to the single digits.
With the latest J&J cash infusion and partnership, ELN now has all the tools to succeed, money & strong pharma support / validation of its pipeline... Two clouds remain, the PML issue, although with no real news or development, continue to be used relentlessly by the short cabal to drive the PPS down every time a case is reported... I don't know how long this will be allowed to go on, as the FDA allows for 1/1000 case to occur and with all the reported case we are well below that rate. The second cloud is the management strength, let's hope they don't waste the new opportunity they've been given. The current stock price does not reflect the new found strength, as a lot of the risk has been removed from stock. I am looking for the low teens in the near future and selling puts to accumulate.
AMLN
What a disappointment this stock has been this second time around! Never, has a management team done so little with so much. They have money, an incredible pipeline, two first and best in class drugs and yet they don't succeed. The root of the problem is the management team and culture that has permeated this company since the beginning. They were essentially a good development team, then after their drugs got approved, essentially did not and still have not changed their mode of operation. They have not been able to successfully switch from being a development biotech to a pharma with products to sell. They have hired poorly and their current CEO is a big part of the problem.. He appears to be a hard worker, but exudes little confidence and is a horrible communicator... Anyway, enough ramblings... What to do?
I am staying put with my holdings, the upside is still great, but I probably will exit in the mid 20's if the pps gets there. The catalyst for a move up in the short terms are..
- A rejection of ligaritude ( a byetta competing drug ) by the FDA.. The FDA should reject or at minimum give them an approvable letter, but you will never know with the FDA as they are for the most part a captured and political agency. Note that Ligar has just been approved in Europe.
- Monotherapy for byetta. Its a decision that's more then 6 months behind schedule. I do not understand why the FDA has not responded yet, scratch that, I do understand, see above comments.
- Clarification of the Byetta label and the removal of the pancreatitis cloud from Byetta. Again, the FDA botched that one. They issued a safety warning for byetta for pancreatitis when the rate of occurrence is at worse equal to the diabetic population. The reality is even more perplexing, since byetta is prescribed to obese patient because of its weight loss proprety, the byetta population is even more prone to pancreatitis. So, the data seems to indicate that Byetta actually decreases the rate of pancreatitis... But go figure our FDA, they issue a warning, what a bunch of boobs!!!
But ultimately, its the role of management to play whatever game the FDA needs them to play to get these things done... And this management team just does not know how to play the game. The recent Icahn and eastbourne BOD wins, have yet to translate to any material changes .
A note of caution. A ligaritude approval could eviscerate the byetta scrips and send the PPS back to the single digits.
Subscribe to:
Posts (Atom)
