Sheff Station

Sheff Station
Contributor since: 2010
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.
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.
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!
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.
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.
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.
Thank you for that information with AIS. I will use that information for a follow up article. Good stuff!
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!
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.
Error was corrected and the proper word of instantaneously replaced my accidental placement of intravenously. Thank you for the attn to this key detail.
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.
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!
Best of success to you! Thx for your message.
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."
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.
AVNR..Clarification here on the Shelf Registration. It is not an offering. A shelf registration is available in case they need funding after the approval of AVP-923. This is not a shelf offering where we will see those shares hitting the open market anytime soon at a specific price point. It is important to remember that the company cannot predict when a partner will come after the approval or if they will want one. They plan to launch this alone! Look at the timing of the shelf registration. 2 months before approval date of AVP-923. When approved those shares are sitting there to take advantage of the increase in market cap of the company. To do an offering now would crush the stock price pre-approval. No worries here on my end. These biotechs are all risky. The goal is to cut down the risk by knowing what you own. If you do have a worry and this is not clear, then maybe this is not the stock for you. Everyone definitely has to make their own decision regarding the risk vs. reward when putting their money in a biotech.
Solid article Jason. The pharma market in Taiwan is severely undervalued IMO. Your ability to highlight the potential there was sound.
w/ ALXA ($2.98) there is no specific time frame on the approval of their manufacturing facility. The way I see it no news is good news! If everything is going smooth they will not release a PR, and if there is a bump in the road that materially affects the PDUFA date then they will need to let shareholders know. That is the company's policy regarding disclosure of FDA interactions as we are less than 60 days from PDUFA.
No SPA but they don't need one. They had a strong end of Phase II meeting with the FDA. No comparative equivalent study vs. loxapine. They did not need to have one. It all comes down to their manufacturing facility because their data is outstanding with the loxapine with Staccato Technology.
Biopharma Investor...thank you for the feedback. Really just trying to provide good information so everyone can make solid and informed decisions. It is a tough market and their is a lot of risk so the more information we are armed with the better. We have 2000 plus members on my blog that I try to share info with and learn from everyday. It is very humbling with the amount of talent you come across whether it be a blog or Seeking Alpha. Keep up the good work.
I think both benefit significantly. AZ-004 is the most advanced product that both Valeant/Biovail companies have collectively in their pipelines. Alexza approval validates their Staccato technology and allows other potential interested partners to come to the forefront. Alexza also has a lot of money to be made upon approval to fund their other products. They become a very attractive buyout candidate in my eyes.
Thank you Gretel. Appreciate the feedback!
$2.70 is right at the offering price so I agree with you in that level as a possible entry as an investor looking out to Oct 11th PDUFA date. The data is solid and so is the technology for Alexza in the Staccato delivery system.
w/AVNR($3.08) The recent share price (dip under $3) does not concern me only because I have seen it before with FDA approval stocks. Prime example is we saw it with Somaxon's (Silenor) where the shorts took that from $4.90 down to $3.60 in 1 day. How easily we can forget when living the moment!
MARCH 2nd ($4.63 high as $4.84)
MARCH 3rd ($3.70ish close) They butchered the stock from close to $5.00 to close it well under $4.00. I was very frustrated and expressed it to everyone but knew what I owned so hung tight.
Encouraging post from a member that same day of the shakeout!
MARCH 11th DD Post re: approval after the stock languished at $3.75-$4.00 for weeks and people were extremely frustrated. I believed it would get approved based on our DD and communicated that to our members! I also gave VNDA as an example (.80 to $11.00) on their approval. Same thing happened with SOMX.
March 19th Sold my shares from $3.90 to over $10. Those shorts had to cover! They took it to over well over $11 from $3.80 after they approved it. I actually got out too early:)
The data is compelling with Avanir and so is the need for AVP-923. There has not been a "first in class" drug approved for Neurologists in 10 yrs. The FDA won't jeopardize not approving this Avanir's drug after the company has spent millions to do additional studies and to comply with their requests via an SPA. That is above and beyond what most companies will do as this drug has been fast tracked since 2006.
BioPharm Investor...thank you with AVNR. AVNR is a solid company that will do very well into October. The clinical data in terms of efficacy and safety is outstanding. I look forward to October being a great month
Solid link Dr. Tucker! That was good to read an article from pubmed. Nice primer of information there on Sodium Oxybate.
Look forward to your next article Rockford. I think that JZP-6 has some solid potential as fibromyalgia is really an untapped market. I believe it will be hard for the FDA panel to keep a drug off the market for societal concerns that #1) is already approved for narcolepsy and #2) demonstrates a clear need for patients.
Larry.. you are correct on the lack statistical significance in MS pts. I was informed by the company that the FDA is looking at the overall patient population (ALS & MS pts) and not a breakdown of the subgroups as the study was not powered to detect a breakdown. Those were not the questions the FDA addressed in the SPA. They had concerns regarding safety which were addressed. MS cohort was much smaller than ALS pts.
"The study revealed that Zenvia 30/10mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo (p=0.0280). The lower dose Zenvia 20/10mg group did not achieve a statistically significant reduction in PBA episode
rates compared to placebo."
So...They met their primary endpoint but did not reach statistical significance. The FDA wanted them to meet their primary endpoint. That was not an issue in the 2006 approvable letter. Zenvia decreased PBA episode rates over course of treatment vs placebo (p<0.0001) which is statistically significant. That is what the FDA is looking at in their approval and well as the success of the 30/10 dose formulation. Best of success. I hope you listened to the Webcast today. It was good.
I addressed this question in my recent article. Take a look at it. Zenvia did reach statistical significance vs. placebo in MS patients. Also...the company is outsourcing the manufacturing of their drug from my knowledge. If that info changes I will let you know. The primary endpoints in the STAR trial are why the drug will get approved. They are solid!
I answered the safety questions in my latest article. I don't believe that AVNR has any issues regarding safety at this point. The FDA made sure they addressed their concerns via the STAR trial. Zenvia was able to address these concerns. Looking forward to Oct. 30th.
I think the target price is lower ($10) on AVNR because of the approvable letter the company received in 2006. People do not fully understand the PBA market and the opportunity that Avanir has in growing that market. 2010 is the year for this company!
AVNR has been down this road before with the FDA in 2006 but this time they have assistance (SPA) and ongoing communication with them. I look forward to the decision in October.
I have been trading on and off since 2001 even though sometimes I feel like a beginner:) Not big into stock clubs or book clubs but I like sharing ideas via this type of forum. Thanks for your message.