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Post by goyocafe on Apr 24, 2018 16:20:51 GMT -5
One question, if this is a week old and is such an important point for Afrezza, why didn't Mannkind PR it a week ago? The fax slipped under the printer cart! 🤠
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Post by madog365 on Apr 24, 2018 16:28:46 GMT -5
Looks like the Spirometry testing requirement is going to go away? Huge barrier for starting patients on afrezza. Is that the correct conclusion from this new fda doc?
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Post by Clement on Apr 24, 2018 16:35:32 GMT -5
Assume Mannkind knew this was coming. Was Mannkind waiting for this to begin advertising -- because now the safety warnings can be less ominous and we get more bang for the buck on advertising?
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Post by sportsrancho on Apr 24, 2018 16:41:58 GMT -5
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Post by tingtongtung on Apr 24, 2018 16:43:38 GMT -5
Any idea what exactly this means, other than speculations?
From all the msgs here and stocktwits: * Spiro is not reqd * Blackbox gone * Pediatric has moved a lot towards the end. * Long term tests can be stopped * etc, etc
Of these, how many are true?
Looks like a good time to buy some and sell before any dilution (if any), and then buy right after that dilution event?
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Post by majorwood on Apr 24, 2018 16:46:48 GMT -5
I think there's alot of exciting developments going on behind the scenes that when made public will be quite beneficial to Mannkind, the Diabetic community, and to us Long and Strong shareholders. This is just a glimpse of what's behind the curtain and there's going to be a title wave soon.
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Post by LosingMyBullishness on Apr 24, 2018 16:52:15 GMT -5
I suggest that people stay cautious: right now there are a lot of shares available thanks to recent dilution that the price can be pulled down again. Usually I bought on such occasions only to be taken down 1h after the start of trading. Disclaimer: still long with calls and shares.
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Post by bill on Apr 24, 2018 16:52:45 GMT -5
A quick search didn't indicate that the removal of a REMS requirement had anything to do with removal of black box warnings or, in our case a requirement for spirometry test. Did anyone find a reference that suggests that the removal of a REMS requirement is, or could be a precursor to other actions?
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Post by peppy on Apr 24, 2018 17:10:38 GMT -5
RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS The REMS for Afrezza (insulin human) inhalation powder was originally approved on June 27, 2014, and the most recent REMS modification was approved on April 20, 2015. The REMS consists of a communication plan and a timetable for submission of assessments of the REMS. In order to minimize burden on the healthcare delivery system of complying with the REMS, we determined that you were required to make the REMS modifications outlined in our REMS Modification Notification letter dated April 17, 2018. Communication Plan: We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals. No further assessments are necessary to assess the current communication plan. Therefore, because the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation powder.
REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients (which includes new salts and new fixed combinations), new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. Because none of these criteria apply to your supplemental application, you are exempt from this requirement.
======================================================================================================== RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS), if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1(a)]. In accordance with section 505-1 of FDCA, we have determined that a REMS is necessary for Afrezza (insulin human) Inhalation Powder to ensure the benefits of the drug outweigh the risk of acute bronchospasm in patients with chronic lung disease. We have also determined that a communication plan is necessary to support implementation of the REMS. Your proposed REMS, submitted on June 20, 2014, and appended to this letter, is approved. The REMS consists of a communication plan and a timetable for submission of assessments of the REMS. Reference ID: 3533688 Reference ID: 3533688 NDA 022472 Page 6 Your REMS must be fully operational before you introduce Afrezza (insulin human) Inhalation Powder into interstate commerce. The REMS assessment plan should include, but is not limited to, the following: 1. REMS communication plan activities: a. Number of healthcare providers and professional societies targeted by the REMS. b. Number of REMS letters sent to healthcare providers and professional societies via email, standard mail, and facsimile, and the dates the letters were sent. Include the number of letters sent via email because the mailed letter was undeliverable. For letters sent via email, include the number of letters successfully delivered, and the number of email letters opened by the recipients. c. Number of REMS Factsheets distributed to healthcare providers by sales representatives and medical liaisons during the reporting period. d. Date the REMS website went live and number of total and unique site visits during the assessment period. e. Names and dates of all scientific meetings during which REMS materials (REMS letters, REMS Factsheet) were distributed 2. Evaluation of healthcare providers’ understanding of: a. The risk of acute bronchospasm associated with Afrezza in patients with chronic lung disease b. Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza c. Afrezza is contraindicated in patients with chronic lung disease d. HCPs should evaluate all patients for lung disease (a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease) before starting on Afrezza 3. Afrezza utilization information including, but not limited to, indication for use and type of prescriber (i.e., endocrinologist, general practitioner, internist, etc.) 4. Safety surveillance: a. Analysis of serious postmarketing case reports of bronchospasm received during the reporting period. Include in the analysis information on whether or not the patient was evaluated for lung disease before receiving Afrezza, and how the patient was evaluated for chronic lung disease (e.g., baseline FEV1, past medical history, physical examination) b. Analysis of postmarketing case reports of serious respiratory adverse events reported for patients with chronic lung disease during the reporting period. Include in the analysis information on whether or not the patient was evaluated for lung disease before receiving Afrezza, and how the patient was evaluated for chronic lung disease (e.g., baseline FEV1, past medical history, physical examination The requirements for assessments of an approved REMS under section 505-1(g)(3) include with respect to each goal included in the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is meeting the goal or whether 1 or more such goals or such elements should be modified. We remind you that in addition to the assessments submitted according to the timetable included in the approved REMS, you must submit a REMS assessment and may propose a modification to the approved REMS when you submit a supplemental application for a new indication for use as described in section 505-1(g)(2)(A) of the FDCA. If the assessment instruments and methodology for your REMS assessments are not included in the REMS supporting document, or if you propose changes to the submitted assessment instruments or methodology, you should update the REMS supporting document to include specific assessment instrument and methodology information at least 90 days before the assessments will be conducted. Updates to the REMS supporting document may be included in a new document that references previous REMS supporting document submission(s) for unchanged portions. Alternatively, updates may be made by modifying the complete previous REMS supporting document, with all changes marked and highlighted. Prominently identify the submission containing the assessment instruments and methodology with the following wording in bold capital letters at the top of the first page of the submission:
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Post by od on Apr 24, 2018 17:11:40 GMT -5
At times like these, I look to/for authority -- Matt, your musings please.
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Post by celo on Apr 24, 2018 17:13:34 GMT -5
A quick search didn't indicate that the removal of a REMS requirement had anything to do with removal of black box warnings or, in our case a requirement for spirometry test. Did anyone find a reference that suggests that the removal of a REMS requirement is, or could be a precursor to other actions? Important Safety Notice The FDA has required this safety notice as part of the AFREZZA REMS (Risk Evaluation and Mitigation Strategy) to inform healthcare providers (HCPs) about the following serious risks of AFREZZA: • Risk of Acute Bronchospasm in Patients with Chronic Lung Disease. • • Appropriate Patient Selection. AFREZZA is contraindicated in patients with: • Chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD) • Patient Evaluation Before Initiating Therapy. • Before initiating, prescribers must perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients, to identify potential underlying lung disease A non-promotional factsheet, reviewed by the FDA, with more detailed safety information on these risks, and a link to the Prescribing Information including the BOXED WARNING are available at www.AfrezzaREMS.com. www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM403785.pdf
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Post by kc on Apr 24, 2018 17:22:08 GMT -5
Dr K effect?? :$ How is that for timing on my recent Dr K. Effect post? I posted it 5 minutes before the after hours started booming. This news feels a lot like David Kendall helped to close this deal with the FDA. Dr. K probably has been working on this for a long time while at Lilly (-; You know what I mean
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Post by od on Apr 24, 2018 17:22:22 GMT -5
Trying to clear the smoke (and this may be an uninformed question) -- Has management shared that safety concerns are a major barrier to provider or payor adoption?
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Post by mnholdem on Apr 24, 2018 17:32:50 GMT -5
So Will there be a press release tomorrow? Maybe this evening?
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Post by wgreystone on Apr 24, 2018 17:34:01 GMT -5
I think it might be even better/huger (if that's a word):
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients (which includes new salts and new fixed combinations), new indications, new
dosage forms, new dosing regimens, or new routes of administration are required to contain an
assessment of the safety and effectiveness of the product for the claimed indication in pediatric
patients unless this requirement is waived, deferred, or inapplicable.
Because none of these criteria apply to your supplemental application, you are exempt from this
requirement. That's what I thought too.. Will it speed up pediatric segment massively? That would be huge! My guess is Afrezza is not yet approved for pediatric patients, so this assessment is not required.
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