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  • MannKind And Afrezza's NDA Evaluation: What Is The Real Justification For The Advisory Committee? [View article]
    Greg

    Fantastic article. Congratulations

    Also visit http://bit.ly/1fvaXxV
    Mar 27 07:28 PM | 7 Likes Like |Link to Comment
  • GCVRZ Forum [View instapost]
    I got a response from FDA for my email
    ------------

    Dear Mr. ----,
    Thank you for writing the Food and Drug Administration (FDA) expressing your support for the approval of alemtuzumab for the treatment of multiple sclerosis.
    We at the FDA share your concern regarding the availability of treatments for multiple sclerosis. With so much at stake, patients and their health care providers count on the FDA to assure that the treatments they choose have demonstrated acceptable safety and efficacy for their intended use through rigorous, objective, scientific testing.

    FDA did not approve alemtuzumab for the treatment of multiple sclerosis, but we cannot say more because FDA is generally prohibited from disclosing information about an unapproved application, including what actions the Agency plans to take on the application. Genzyme Corporation can choose to share FDA’s concerns with you. You may contact Genzyme Corporation and request a copy of our letter concerning the alemtuzumab application.

    Please be assured that FDA is extremely concerned about patients with multiple sclerosis. Although we have approved a number of new drugs for multiple sclerosis during the past few years, we recognize that the disease is far from cured, and there remains an acute need for new therapies that are safe and effective. We will continue working diligently and collaboratively with Genzyme Corporation to determine what further information is needed to support approval. We remain committed to working with all stakeholders to encourage the development and approval of safe and effective treatment options for patients.
    Sincerely,
    Catherine Chew, PharmD
    Acting Director, Division of Drug Information
    Center for Drug Evaluation and Research
    Food and Drug Administration
    ----------------------...
    Mar 5 05:53 PM | 2 Likes Like |Link to Comment
  • Prana Biotechnology And MannKind Corp.: Bad News Obeys Its Own Special Laws [View article]
    Are you sitting down?
    The reason that I got from SA editors is that there are already many articles published on Afrezza.
    Feb 20 05:38 PM | 4 Likes Like |Link to Comment
  • Are We Heading For A Recession In 2014? [View article]
    If both short term and long term are close to zero, you'll get recession. the banks profits evaporate if long end drops.
    Feb 7 01:45 PM | Likes Like |Link to Comment
  • Are We Heading For A Recession In 2014? [View article]
    These graphs are too volatile to make any good prediction
    Feb 7 01:45 PM | Likes Like |Link to Comment
  • Why MannKind Is My 2014 Short Pick In Healthcare [View article]
    Here , take my one cent from page view. That is all this article deserves.
    Jan 17 06:54 PM | 1 Like Like |Link to Comment
  • Best Ideas For 2014: Long GCVRZ [View article]
    Any one can email FDA, your standing is as a concerned citizen. Here is my email.
    ----------------------...
    Date: Thu, Jan 16, 2014 at 9:03 PM
    Subject: FDA's CRL for Lemtrada
    To: Margaret.Hamburg@fda.h...
    Cc: druginfo@fda.hhs.gov, PCNS@fda.hhs.gov, janet.woodcock@fda.hhs...


    Dear Dr. Hamburg

    I am writing to express my disappointment and frustration with the FDA's decision to issue a CRL regarding the Lemtrada (MS drug) application.

    It speaks volumes of the poor quality of decision making progress, lack of leadership, and utter lack of concern for the well being of the MS patients. Lemtrada has been approved in 30 countries. Genzyme completed their trials as per the FDA's initial guidelines.

    Please read Nobel Laureate Dr Alasdair Coles's comment regarding FDA's decision.
    http://bit.ly/1ktQrpR

    "Unexpectedly, and disappointingly, the FDA has recently decided, against
    the recommendation of its advisory board, that alemtuzumab should not be approved in the United States (see here). The FDA argued that the clinical trials of alemtuzumab are not reliable because patients and doctors were not “blinded” to the treatment they were receiving. Our view is that the side-effects of an infusion of alemtuzumab are so immediate, universal and well-known, that attempts at blinding would be futile. So, like nearly all trials in multiple sclerosis, we relied on a blinded “rater” to assess participants’ disability, backed up by MRI measures. None of the Cambridge team was asked to contribute to the discussions between the FDA and Genzyme, but reading the public details (found amongst other places here, under the November 13th meeting) leaves me concerned at the quality of decision-making by the FDA. In our opinion, this decision denies people with multiple sclerosis in the United States from an important treatment option."


    Also read DeMuth article in WSJ today. http://on.wsj.com/LcN46r

    FDA had approved Tysabri, that has less efficacy and more side effects compared to Lemtrada. FDA's decision to issue CRL for Lemtrada is just politically motivated. Genzyme (the sponsor) is appealing the decision. I hope you would personally look into this matter and provide this drug as an option for the long suffering MS patients.

    Regards
    Jan 17 04:31 PM | 1 Like Like |Link to Comment
  • Comment To The FDA Regarding The Lemtrada Appeal [View instapost]
    I dont know if this was mentioned earlier. Kudos to DeMuth Sr and Jr. for the opinion article in WSJ

    The FDA Nixes a Pathbreaking Drug for MS
    http://on.wsj.com/LcN46r
    Jan 16 09:42 PM | 2 Likes Like |Link to Comment
  • MannKind's Day Of Reckoning Is Getting Very Close [View article]
    Good article, but bad title.

    day of reckoning
    n
    1. a time when the effects of one's past mistakes or misdeeds catch up with one
    Jan 13 11:07 AM | 2 Likes Like |Link to Comment
  • 20 Reasons Why Mannkind's Afrezza Is Superior To Novolog/Humalog [View instapost]
    Hi Pat

    I know you from the diabetes forum, IN fact I had put your experience in my blog years back

    http://bit.ly/1cCWf9F

    Thank you for your comment and hope FDA approves Afrezza this time
    Jan 8 09:25 PM | Likes Like |Link to Comment
  • Comment To The FDA Regarding The Lemtrada Appeal [View instapost]
    Thanks Chris for initiating this. The MS patients voice matters.
    Jan 7 12:29 PM | 5 Likes Like |Link to Comment
  • The Best Case Scenario For Sanofi Rights (GCVRZ) After FDA's Complete Response Letter [View article]
    Rootbeer
    To me, everything boils down to meeting $400m milestone. What do you think is the probability of achieving that? They got a year to ramp up salesforce and then have to count the next 4Q sales
    Jan 3 06:17 AM | Likes Like |Link to Comment
  • The Best Case Scenario For Sanofi Rights (GCVRZ) After FDA's Complete Response Letter [View article]
    the details on sales can be tracked in this link

    http://bit.ly/1ddvwOm

    If say the drug was launched in Jan-2014 in Germany, after the first anniversary, the four quarters sales are considered (ie Q1-Q4 of 2015).

    if drug is launched in UK in Mar-2014, then the sales of Q2-15 to Q1-16 be considered. All these sales will be added up to get $400MM
    Jan 2 12:38 PM | 2 Likes Like |Link to Comment
  • GCVRZ Forum [View instapost]
    My article on GCVRZ just got published in SA

    http://seekingalpha.co...
    Jan 2 12:09 PM | 5 Likes Like |Link to Comment
  • GCVRZ Forum [View instapost]
    http://1.usa.gov/1hcRl7I

    http://1.usa.gov/Kh6zud
    Dec 31 12:54 PM | 1 Like Like |Link to Comment
COMMENTS STATS
36 Comments
34 Likes