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bernardc

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  • Arena - Belviq Sales Up Modestly Heading Into Television Ads [View article]
    Nice analysis!
    Apr 11, 2014. 02:03 PM | 2 Likes Like |Link to Comment
  • MannKind up big premarket [View news story]
    Are the 13-1 and 14-0 votes by the Advisory Committee sufficient to entice a partnership deal before the PDUFA decision by the FDA due April 15? Is big pharma in a better position to bargain right now with there still being a risk of FDA rejection - or more likely onerous label restrictions? In any event, deal is imminent. Place your bets.
    Apr 2, 2014. 07:13 AM | 3 Likes Like |Link to Comment
  • MannKind - A Trail Of Failure Leading To Success [View article]
    Excellent article.
    Apr 1, 2014. 11:25 AM | 3 Likes Like |Link to Comment
  • Strange Goings On In The VirnetX Vs. Apple Case [View instapost]
    I hope you are "bored" again soon.
    Mar 28, 2014. 04:23 PM | 4 Likes Like |Link to Comment
  • AFREZZA Ad comm meeting April 1 [View news story]
    From my very inexpert perspective I have to say the briefing docs conclusions are not very positive. But draw your own conclusions:
    CONCLUSIONS
    The primary analysis from the T1DM trial (Study 171) met the criterion that TI (prandial insulin), delivered via a Gen2 inhaler, was non-inferior to insulin aspart in lowering HbA1c after 24 weeks of treatment in subjects whose disease were suboptimally controlled with their current basal insulin regimens (insulin glargine, insulin detemir, or NPH insulin). However, the comparative efficacy shown here was not compelling since the upper bound (0.37%) of the 95% CI of the treatment difference (TI-Gen2 minus insulin aspart) in change from baseline in HbA1c at Week 24 was almost right at the boundary of the pre-specified margin (0.4%), and the mean reduction in the TI-Gen2-treated patients was actually statistically significantly worse (by an estimate of 0.22%) when compared with that in the insulin aspart-treated patients. There were 25% and 11% dropouts in the TI-Gen2 and insulin aspart treatment arms which could have potentially impacted the primary non-inferiority analysis. Among the sensitivity analyses conducted by the sponsor, all showed similar findings to the primary analysis except for the multiple imputation under the non-inferiority null method where 0.4% was added to every discontinued patient in the TI-Gen2 group. That analysis showed a treatment difference of 0.3% (TI-Gen2 minus insulin aspart) with 95% CI = (0.15%, 0.48%), failing to satisfy the non-inferiority criterion. The 95% confidence intervals for the primary and sensitivity analyses were all above zero, demonstrating that TI-Gen2 was inferior to insulin aspart in the HbA1c change from baseline to Week 24. There were approximately 55% and 73% of the TI-Gen2 and insulin aspart treated patients, respectively, having an improved HbA1c level (i.e., change < 0) after 24 weeks of treatment. At Week 24, the TI-Gen2 treated patients had a mean decrease in body weight from baseline (-0.5 kg), while the insulin aspart treated patients showed a mean increase (+0.9 kg). For any definition of hypoglycemic episodes (e.g., severe, mild/moderate, and all), the proportion of patients experiencing at least 1 specific event was lower in the TI-Gen2 group than in the insulin aspart group. Both the mean daily prandial and basal insulin doses used in this T1DM open-label trial were consistently higher in the TI-Gen2 group than in the insulin aspart group.
    Data from the T2DM trial (Study 175) have demonstrated that TI, delivered via a Gen2 inhaler, was statistically superior to placebo in lowering HbA1c after 24 weeks of treatment in subjects whose disease were suboptimally controlled on optimal/maximally tolerated doses of metformin only or 2 or more OAD agents. However, the treatment difference (TI-Gen2 minus placebo) in change from baseline in HbA1c at Week 24 was modest (-0.4%). There were 21% and 30% dropouts in the TI-Gen2 and placebo treatment arms (15% and 21%, respectively, if rescued and completed patients were discounted) which could have potentially impacted the primary superiority analysis. However, among the sensitivity analyses conducted, all showed similar findings to the primary analysis. There were approximately 86% and 72% of the TI-Gen2 and placebo treated patients, respectively,
    Mar 28, 2014. 10:54 AM | Likes Like |Link to Comment
  • MannKind And Afrezza's NDA Evaluation: What Is The Real Justification For The Advisory Committee? [View article]
    Thank you for this thoughtful, professional and timely article
    Mar 27, 2014. 06:52 PM | 8 Likes Like |Link to Comment
  • MLV Sees A Good Chance Of FDA Approval For MannKind's Afrezza And 60% Upside [View article]
    About as solid a report as one could expect at this stage. Probably very conservative on the stock forecast, but a strong partnership could result in a much better number.
    Mar 18, 2014. 12:15 PM | 8 Likes Like |Link to Comment
  • Thank You For Riding The MannKind Catalyst Train - Please Exit Safely At The Next Available Station [View article]
    OK. Now every nit has been picked. What seems to be overlooked is that Afrezza was not the issue in the previous FDA rejection, but that the new inhaler was not part of the previous trial (s). The Dreamboat appears to have passed with flying colors. (In the back of my mind is also the FDA insider scandal last time with the final decision apparently only the result of an inability of the top echelon at FDA being able to recognize engineering mechanics.)
    However, if the Novo rep chairs the AdCom I'll quickly agree with the doubters.
    Feb 27, 2014. 02:27 PM | 4 Likes Like |Link to Comment
  • Thank You For Riding The MannKind Catalyst Train - Please Exit Safely At The Next Available Station [View article]
    OK. Now every possible nit has been picked. Bottom line to me is that Afrezza was not the issue for the earlier rejection, but substituting the new inhaler was. (In the background is also the FDA scientist who thought up to the last minute the plan was for approval and with insider info bet accordingly only to be suprised by the last minute change in the decision.)
    If the chair of the AdCom is the Novo rep I'll change my mind.
    Feb 27, 2014. 02:17 PM | 11 Likes Like |Link to Comment
  • New Bay LLC Is Authorized To File Motions To Terminate Their IPRs - Apple Can Not Oppose [View instapost]
    Great reporting Tom. Do you think VirnetX might sue New Bay for attempted extorsion and collect legal fees?
    Nov 1, 2013. 10:43 AM | Likes Like |Link to Comment
  • Dear Apple Shareholders And Customers: What Apple Should Be Disclosing To You [View article]
    Stay tuned for judge Davis' royalty decision. And then the Cisco re-trial. And then the next Apple trial. An exciting fall (no pun intended) ahead for Apple!
    Aug 18, 2013. 10:37 AM | 4 Likes Like |Link to Comment
  • A VirnetX Short Squeeze May Be Setting Up [View article]
    Have you had occasion to consider the presence of Reverse Conversions in your short squeeze analyses? A substantial number have been established in VHC over the past two years, at least several million shares "rented" from MMs since late last year.
    May 13, 2013. 09:29 AM | Likes Like |Link to Comment
  • Is Dendreon Done After Q1 Train Wreck? [View article]
    So Scher/Milken/VonEschen... win by TKO or knockout?
    May 10, 2013. 10:19 AM | Likes Like |Link to Comment
  • The Dendreon Bear Raid Of 2009: Chasing The Perpetrators [View article]
    Ted: the U of Michigan doctor is Maha Hussain. I tried to get the M president to investigate her, but all I got was a threatening letter from the M legal department. When Von Eschenbach retired and showed up at Milken's PC non-profit, when Allison Martin left NIH and showed up there after her computer was shown to have been involved in the leaked letter to Von E, when Martin showed up with Scher and Hussain at a celebration of a PC trial result, one might have thought there was a basis for an FDA inspector general investigation. Even Kerry Dublin's dramatic efforts couldn't get the IG to do anything. Astounding!
    Mar 6, 2013. 10:19 AM | Likes Like |Link to Comment
  • The Dendreon Bear Raid Of 2009: Chasing The Perpetrators [View article]
    Ted: I left DNDN after the Aug. 2 crash, but fortunately did well before that. I probably posted about the U of Michigan doctor on the AC in 2007 who dozed off and voted no (Hussain.) I complained to the President of M at the time being an M graduate and received a thretening letter back from M's legal department. At the same time, I have an old friend who was a lobbyist for M at the time who knew John Dingell very well. M's doctor's involvement in this issue if Dingell had investigated would have been a substatial embarrassment to M and I thought then and think now M lobbying influenced Dingell.
    I happened to sit right behind the DNDN Exec. Com. during the AC in 2007, and who should be sitting next to me but a woman from Scher's SF company. Got her e-mail address and tried to track her down later when the trial Scher directed failed due to excessive deaths. Still want to regurgitate when I think of Scher's brazen statement about economic interests being involved when his turn came at the AC.
    Who was the gal from NIH whose computer records indicated she wrote the letter that went to VonEshenbach------, Allison something, who quickly left NIH and showed up briefly at Milken's PC non-profit? And later I found her name with Scher at an event celebrating a PC clinical trial result involving Hussain.
    Well, I've graduated to trying to expose "reverse conversions" with Ming at VirnetX. But the pain from DNDN will never go away.
    Haven't heard much about Pazdur lately. Is he still around?
    Altlurker
    Mar 5, 2013. 08:01 PM | Likes Like |Link to Comment
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