Tracking Short Positions of 3 Biotechs With PDUFA Dates in January [View article]
Great points Rocky on the charts and on the market sentiment for thoughts on drug approvals! CLDA and OREX have large short positions. Nothing is an absolute but it does seem the short interest can be used as a predictor of market sentiment. I use the charts from this link. www.dailyfinance.com/c...
Appreciate your comments. I would like to see more accurate short data with info from January. It seems the reporting is about 2-4 weeks behind with latest numbers being 12/15/10.
Celsion Positioned for Breakthrough Year in 2011 [View article]
This was a major wording error in my article: “This allows for a potential approval in Q4 as they have a rolling NDA and a six month priority review for their Phase III SPA trial for primary liver cancer”
It should have stated " This allows for a potential date PDUFA date in Q4 2011 and not approval in Q4.
The error has been corrected in my article and I appreciate you bringing it to my attention.
I will reserve comments on your other points about the "flaws" in my financial analysis of the company. An investor can look at the 10Q and determine how they deciper the financial state of the company. Thanks!
Celsion Positioned for Breakthrough Year in 2011 [View article]
The 2nd risk (failed trial results) is one I assumed people already knew was a risk but I still should have been included because a failed trial is the biggest risk to an investor. This omission has been corrected and a change has been made to my article.
I have to look into the IP situation for AMRN product AMR101. Very good question that I dont have the answer to. I would think they have more than one patent application on their technology , because it is so valuable, but I do not know.
Avanir Trading Volatility and Increased Short Interest in September Provides Promising Opportunity [View article]
Lens Cap... or pianobenchpress? Whichever you are today. You should put me on ignore if you don't like what I have to say. I could care less what you have to say its just you like to respond to me for your own comfort! People know where I stand and trust me and that is why I have a loyal following and will continue to. You on the other hand?? I post my thoughts on my personal blog and no where else. If people don't like my info or what I have to say they move on. You should do that and move on! I wont be responding to you ever again, but I just thought this needed to be said.
Biosante: Key Catalysts Should Renew Investor Interest [View article]
Thank you for the BPAXAIS information and how closely the two are linked! Sounds like one that I really need to look closer at especially given the potential and where the market cap is.
Biosante: Key Catalysts Should Renew Investor Interest [View article]
Thank you sir! The thought is that this market is significantly underserved and that this market could be huge with you consider other factors that come into play. Would be big for Biosante as they would be the lone player in a billion dollar market. Time will tell but these biotechs have to start somewhere and the clinical studies are in place to answer key questions that the FDA wants to know. All the best! www.minyanville.com/bu...
Avanir Trading Volatility and Increased Short Interest in September Provides Promising Opportunity [View article]
Never played ARNA into approval. Risk was written all over that stock. Not sure of anything. I just post my thoughts and opinions based on what I see. I really like AVNR and believe AVP-923 gets approved. There is definite risk whether you are short or long so play the stock swings and trade it accordingly.
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
Error was corrected and the proper word of instantaneously replaced my accidental placement of intravenously. Thank you for the attn to this key detail.
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
The Staccato system vaporizes drugs instantaneously (should not be intravenously)That slipped right by me when I reread my notes. I just read it wrong. Apologize for my error! I am going to see if I can get that word corrected.
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
The Staccato system vaporizes drugs instantaneously (should not be intravenously) to create aerosols that look like you have given someone and injection (Staccato Technology Animation Video). That was an error on my part in verbage! I attached PDF files so that people could see. That slipped right by me when I reread my notes. Apologize for my error!
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
Comments regarding manufacturing for ALXA! "The PDUFA goal date for our AZ-004 (Staccato loxapine) NDA is October 11, 2010. During the past several months, the FDA has conducted and completed NDA-based inspections of our manufacturing facility, and several clinical and non-clinical sites, which appear to be part of the normal course of the ongoing NDA review," said Thomas B. King, Alexza President and CEO. "As we approach the PDUFA goal date, we expect continued interaction and contact with the FDA regarding our NDA submission. We are not planning on making any specific comments on the details of these interactions unless we feel we have material information that will impact our PDUFA date."
Avanir Expected to Shine at the American Neurological Association Meeting [View article]
The AVNR recent Form 4 as well as all the others since May are part of their 10b5-1 plan for officers that was put in place as early as October of 2009. This one by Keith Katkin was put in place on December of 2009. These are pre-arranged dates and is a pre-arranged trading plan. This allows officers to sell their stock without knowledge of material non-public information. They cannot change their mind about selling shares knowing there is an upcoming PDUFA date. That is why they do this so far in advance! Also these shares are sold to cover taxes on restricted stocks units vesting that have been previously given/awarded to officers. These transactions are a normal part of business for officers but everyone has to do what works for them when purchasing a biotech. There will be volatility in all of these companies.
Tracking Short Positions of 3 Biotechs With PDUFA Dates in January [View article]
www.dailyfinance.com/c...
Appreciate your comments. I would like to see more accurate short data with info from January. It seems the reporting is about 2-4 weeks behind with latest numbers being 12/15/10.
Celsion Positioned for Breakthrough Year in 2011 [View article]
It should have stated " This allows for a potential date PDUFA date in Q4 2011 and not approval in Q4.
The error has been corrected in my article and I appreciate you bringing it to my attention.
I will reserve comments on your other points about the "flaws" in my financial analysis of the company. An investor can look at the 10Q and determine how they deciper the financial state of the company. Thanks!
Celsion Positioned for Breakthrough Year in 2011 [View article]
Amarin: Pending Catalysts, Potential Breakthrough [View article]
Avanir Trading Volatility and Increased Short Interest in September Provides Promising Opportunity [View article]
Biosante: Key Catalysts Should Renew Investor Interest [View article]
Biosante: Key Catalysts Should Renew Investor Interest [View article]
Biosante: Key Catalysts Should Renew Investor Interest [View article]
www.minyanville.com/bu...
Avanir Trading Volatility and Increased Short Interest in September Provides Promising Opportunity [View article]
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug [View article]
Alexza's Staccato: Setting Up as a New Platform for 'Inhalation Technology' [View article]
"The PDUFA goal date for our AZ-004 (Staccato loxapine) NDA is October 11, 2010. During the past several months, the FDA has conducted and completed NDA-based inspections of our manufacturing facility, and several clinical and non-clinical sites, which appear to be part of the normal course of the ongoing NDA review," said Thomas B. King, Alexza President and CEO. "As we approach the PDUFA goal date, we expect continued interaction and contact with the FDA regarding our NDA submission. We are not planning on making any specific comments on the details of these interactions unless we feel we have material information that will impact our PDUFA date."
finance.yahoo.com/news...
Avanir Expected to Shine at the American Neurological Association Meeting [View article]