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Robert Schwartz

 
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  • Why AVEO Pharmaceuticals' Tivozanib Will Be Approved For The Treatment Of Advanced Renal Cell Carcinoma [View article]
    Thanks Pete, will try and find the time.
    Dec 7 10:20 AM | Likes Like |Link to Comment
  • Why AVEO Pharmaceuticals' Tivozanib Will Be Approved For The Treatment Of Advanced Renal Cell Carcinoma [View article]
    It's early but I readily acknowledge my miss on AVEO!
    Dec 6 09:07 AM | 1 Like Like |Link to Comment
  • Why AVEO Pharmaceuticals' Tivozanib Will Be Approved For The Treatment Of Advanced Renal Cell Carcinoma [View article]
    I am still a GALE bear and haven't yet done diligence assessments on IMUC or NW.
    Dec 5 09:25 AM | Likes Like |Link to Comment
  • Why AVEO Pharmaceuticals' Tivozanib Will Be Approved For The Treatment Of Advanced Renal Cell Carcinoma [View article]
    They have certainly had a good run of late!
    Dec 3 08:19 AM | Likes Like |Link to Comment
  • Peregrine Pharmaceuticals' Bavituximab: It's Time To Throw In The Towel [View article]
    My advice was that investors throw in the towel. PPHM will not throw in the towel until the goose stops producing their salaries.

    Their data doesn't merit a BTD.
    Nov 25 05:09 PM | Likes Like |Link to Comment
  • Quick Take On Vical's Allovectin Failure [View article]
    Excellent summary!
    Aug 14 01:30 PM | 1 Like Like |Link to Comment
  • Newlink Genetics' Pancreatic Cancer Vaccine Likely To Disappoint Investors In 2013 [View article]
    Patrick is usually correct when making PTRS predictions so perhaps I was overly optimistic,
    Jul 18 03:21 PM | 2 Likes Like |Link to Comment
  • Newlink Genetics' Pancreatic Cancer Vaccine Likely To Disappoint Investors In 2013 [View article]
    Thanks for the question. The 15-20% number refers to the probability of a successful Phase-III outcome and I still stand by this number.

    Regards,

    Robert
    Jul 17 01:42 PM | Likes Like |Link to Comment
  • Peregrine Pharmaceuticals' Bavituximab: It's Time To Throw In The Towel [View article]
    The FDA will expedite approval of drugs with the so-called "Breakthrough Designation". The designation does not obviate the need to conduct studies that demonstrate the effectiveness of the drug.

    I said that a large, well-powered study would have been required for PPHM to have garnered an SPA for Bavi. The elected not to do the study recommended by FDA and the approval of Bavi (assuming a positive Phase III trial) will be a review issue.

    I good sized study is necessary to "tease out" the differential activity of the Bavi combination.

    Robert
    May 31 01:38 PM | Likes Like |Link to Comment
  • Peregrine Pharmaceuticals' Bavituximab: It's Time To Throw In The Towel [View article]
    A large well powered study would have gotten them an SPA.
    May 28 10:59 AM | Likes Like |Link to Comment
  • Peregrine Pharmaceuticals' Bavituximab: It's Time To Throw In The Towel [View article]
    Truffle,
    A company is free to conduct any study they choose to register a drug and it is up to the FDA to determine if the data from that trial supports registration.

    Recently, companies looking to eliminate some of the risk of their registrational trials have sought agreement from the FDA (under a Special Protocol Assessment or SPA) on trial design and an outcomes that would confer an approval. Note, however, that there was NO mention of an SPA in PPHM's press release which implies that the results from the trial will be determine during FDA's review. One must conclude that PPHM and FDA could not agree on terms and conditions for an SPA. This action supports my skepticism.
    May 27 09:15 PM | Likes Like |Link to Comment
  • Peregrine Pharmaceuticals' Bavituximab: It's Time To Throw In The Towel [View article]
    PPHMstockofcentury,

    The answer is no to both questions. I have no hidden agenda; I simply call it as I see it.

    Robert
    May 25 01:19 PM | Likes Like |Link to Comment
  • Why AVEO Pharmaceuticals' Tivozanib Will Be Approved For The Treatment Of Advanced Renal Cell Carcinoma [View article]
    Indeed I was, a humbling experience!
    May 3 09:38 AM | 1 Like Like |Link to Comment
  • Why AVEO Pharmaceuticals' Tivozanib Will Be Approved For The Treatment Of Advanced Renal Cell Carcinoma [View article]
    FDA asked the Advisory to consider whether a second trial is necessary and this drove Aveo's share price lower. I continue to believe that the current body of data will support approval but I am increasingly in the minority. I think a reasonable outcome would be to grant tivo a "conditional" approval with full approval contingent on a second study. If I were Aveo, I would use placebo as the comparator in the second study (per the Axitinib and other agents).
    Apr 30 09:59 PM | 1 Like Like |Link to Comment
  • Newlink Genetics' Pancreatic Cancer Vaccine Likely To Disappoint Investors In 2013 [View article]
    Who said anything about allovectin working??? I do not believe that it does.

    R
    Apr 29 02:22 PM | Likes Like |Link to Comment
COMMENTS STATS
182 Comments
48 Likes