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AVEO Pharmaceuticals, Inc. Message Board

  • htgute htgute Feb 16, 2013 12:04 PM Flag

    what happened to enrjrr? Did he sell?

    Havent heard from him in a while

    Sentiment: Hold

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    • (5) Both the CEO and Henri Termeer (Board member, CEO of Genzyme) have been buying shares on the open market. While most insider trades may not raise an eyebrow (or two), these are important. Why? Well, both Termeer and CEO Ha-Ngoc ALREADY HAVE tons and tons of options. They are already heavily invested and incentivized for the stock to go up. Despite that - they are dipping into their own wallets to buy more shares on the open market. This is a huge sign of confidence in the outcome of the ODAC/FDA decision. These purchases have all occurred within the last 6 months as AVEO stock has dropped to the $6-$7 range. While this is no guarantee that tivozanib gets approved, both the CEO and Termeer are extremely confident. Good sign in my opinion - especially in light of the shares that each already owns.

      GLTA. This stock has been hammered by naysayers, uninformed investors in oncology stocks, and shorts/hedge funds. Redemption is less than 60 days away (ODAC meeting).

      • 2 Replies to enrjrr
      • Bump Enrjrr post worth repeating:

        (5) Both the CEO and Henri Termeer (Board member, CEO of Genzyme) have been buying shares on the open market. While most insider trades may not raise an eyebrow (or two), these are important. Why? Well, both Termeer and CEO Ha-Ngoc ALREADY HAVE tons and tons of options. They are already heavily invested and incentivized for the stock to go up. Despite that - they are dipping into their own wallets to buy more shares on the open market. This is a huge sign of confidence in the outcome of the ODAC/FDA decision. These purchases have all occurred within the last 6 months as AVEO stock has dropped to the $6-$7 range. While this is no guarantee that tivozanib gets approved, both the CEO and Termeer are extremely confident. Good sign in my opinion - especially in light of the shares that each already owns.

        GLTA. This stock has been hammered by naysayers, uninformed investors in oncology stocks, and shorts/hedge funds. Redemption is less than 60 days away (ODAC meeting)

      • I have little doubt Tivozanib gets recommended by the advisory board and gets approved. My doubts are whether the stock acts appropiately and actually goes up into the $10 range. The secondary offering and the way this is being pumped as being in question makes me wonder if its not being set to roll over and settle into the $5 range on good news, as it may take a buyout or big stock buyback to move it upward, not an FDA ruling.

    • I have not sold. In fact, I have added additional shares in the 6s to bring my cost down. Many of the points that I have shared in earlier posts, I still believe in. Stronger now than ever. Here is a rundown of why tivozanib will be approved - and why AVEO is easily a $15 stock. (1) Tivozanib's overall survival results were confounded by the imbalance in patients receiving additional lines of therapy for their RCC. In most trials, the randomization is such that there is a relative balance between two arms. Due to the international design of the trials, many of the responders to tivozanib were patients in ex-US markets - where 2nd line of therapy is not always provided by the government backed healthcare plan. This is significant - and IMO - has been underestimated and underappreciated by the stock market. Analysis has shown that those patients that received two lines of therapies showed an improvement in OS favoring tivozanib. (2) AVEO could NOT have prevented this discordance in results between PFS and OS. The choice to allow for sorafenib patients to cross-over to tivozanib is an ethical decision - and a decision that helps physicians convince patients to enroll in the study. If a patient was concerned that they would be randomized to sorafenib (and not receive tivozanib upon their disease progression), the trial would not be worth the additional visits, check-ups, tests, and poking and prodding. Companies build crossover into their trials to help with enrollment and to address this ethical dilemma for physicians. This decision hurt AVEO - and if the drug is not approved, will set a dangerous precedent for future trials in RCC. The FDA knows this - as will the ODAC committee. A decision to reject tivozanib will be squarely based upon the difference between PFS and OS. This kind of decision will have hue ramifications for RCC and other cancer research in the future. In fact, it might slow down the research needed to make progress.

      • 3 Replies to enrjrr
      • No postings by ENRJRR??? You disputed all my concerns re AVEO even though i made a profit by selling in early 2012. Still holding Mr Everlasting Aveo bull? I think you are smart, by the way, but not necessarily a prudent biotech investor

      • bump....read this thread...it is worth a revisit

      • (3) FDA is putting much more weight on tolerability and safety in the oncology space. Tivozanib offers clearly the safest option for patients among the many TKIs approved for RCC. You can debate the efficacy parameters - but the bottom line is that tivozanib also has the longest PFS in the first-line setting - and the ONLY drug with 12 months+ PFS. These numbers are undeniable - and offer the promise of being a best-in-class agent for both safety and efficacy. The confounding effects that negatively impacted the OS trends have not dragged down other drugs toward gaining RCC approval - and this will be no different. The standard has been PFS - and it remains PFS. (4) The FDA asked for more information about the OS trends simply b/c there was a negative trend between the two arms favoring sorafenib. Before the information was disclosed about the major imbalances between the two arms - the FDA raised some questions - as they should. With the benefit of hindsight, investors can see why these imbalances likely impacted the OS trends for both arms - however, at the time of the FDA's communication - they were unaware of these imbalances. Since this communication, there have been no further updates from the FDA. There have been updates to the survival numbers - and the story remains similar to the original ASCO presentation. There is an OS trend favoring sorafenib but 3x the number of patients in that arm received 2nd line therapy vs. the tivozanib arm. This is not balanced. Additional treatment helps patients live longer - and this has been shown in this study. Anyone that questions this fact does not understand oncology. If you are not treated, you will die sooner. Plain and simple. Sorafenib patients received more treatment due to demographic factors that were variable according to where patients were treated. Unfortunate - but uncontrollable by AVEO or any of the investigators. The ODAC committee will recognize this - and identify it as reasonable.

 
AVEO
1.27+0.08(+6.72%)Sep 19 4:00 PMEDT

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