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Post by centralcoastinvestor on Apr 24, 2018 15:29:15 GMT -5
There is a lot of action going on after hours right now. What’s up?
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Post by mannmade on Apr 24, 2018 15:33:08 GMT -5
Dr K effect?? :$  |
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Post by babaoriley on Apr 24, 2018 15:33:26 GMT -5
We're saved!!! Fingers crossed!
martin shkreli reaching out from his prison cell!!
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Post by robbmo on Apr 24, 2018 15:33:41 GMT -5
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Post by boca1girl on Apr 24, 2018 15:34:33 GMT -5
Wow, up 10%. Yahoooooo!
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Post by peppy on Apr 24, 2018 15:36:47 GMT -5
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.
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Post by centralcoastinvestor on Apr 24, 2018 15:37:00 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. |
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Post by epc1355 on Apr 24, 2018 15:38:02 GMT -5
REMS? So what does this mean?
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Post by centralcoastinvestor on Apr 24, 2018 15:39:54 GMT -5
REMS? So what does this mean? I think it means that the FDA declared that Afrezza is safe. Period. That is big news. |
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Post by robbmo on Apr 24, 2018 15:42:40 GMT -5
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. Does this mean the spirometry requirement is going to go away as well? |
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Post by mnkdfann on Apr 24, 2018 15:46:22 GMT -5
www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=319What is the purpose of the REMS? The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by: Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease. Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD. Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease. Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA. --- See the MATERIALS tab at the link I gave above to see the information about what Mannkind had to do. It looks like they no longer have to send certain cautionary letters out to providers and others, but that is based on a really quick look. I'm not sure if it is a big deal or not.
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Post by peppy on Apr 24, 2018 15:48:55 GMT -5
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. Does this mean the spirometry requirement is going to go away as well? 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. www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdfpage 5 |
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Post by robbmo on Apr 24, 2018 15:50:31 GMT -5
Does this mean the spirometry requirement is going to go away as well? 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. www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdfpage 5 In looking at it, I believe the spirometry requirement might go away as the lung testing is part of the REMS... |
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Post by boca1girl on Apr 24, 2018 15:52:18 GMT -5
It would be nice to have a press release from MNKD on this subject.
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Post by dg1111 on Apr 24, 2018 15:52:41 GMT -5
REMS? So what does this mean? I think it means that the FDA declared that Afrezza is safe. Period. That is big news. Could that be applied to Technosphere generically? |
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