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Post by sayhey24 on Apr 24, 2018 20:41:56 GMT -5
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Post by lakers on Apr 24, 2018 21:07:59 GMT -5
• MannKind (NASDAQ:MNKD) is up 8.1% after hours following a letter from the FDA saying that the company's Afrezza inhalation treatment no longer needs a Risk Evaluation and Mitigation Strategy. • "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," the FDA writes. • With that, a REMS is no longer required for the powder, the FDA says MannKind +8% as FDA clears risk hurdles for Afrezza www.seekingalpha.com/news/3348257 |
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Post by agedhippie on Apr 24, 2018 21:55:05 GMT -5
The plan of action (REMS) is no longer needed because it is completed. The FEV1 and all the other requirements are still in place since they were not part of the REMS. The REMS itself and the material making it up is in this link - Afrezza REMS. Look at the goals of the REMS. |
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Post by mango on Apr 24, 2018 22:22:08 GMT -5
Since the FDA has informed MannKind that a REMS is no longer required for Afrezza, then that means the following are no longer required and are not an issue:
1. Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease.
2. Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD.
3. Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease.
4. Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA.
The REMS is a program required by the FDA to manage known and/or potential serious risk(s) associated with a product. The FDA has determined that any and all risks associated with Afrezza described and detailed in the REMS is no longer seen as a potential health risk, hence, the REMS is no longer required. Put simply, the benefit outweighs the risk and the FDA is no longer requiring a REMS and Afrezza is no longer associated with the risks described in the REMS and is unchained from any and all details described in the REMS.
If you will take note and notice number 4 there as a goal of the REMS, or should I say, plan of action, it is referring to the spirometry.
FEV1 and Black Box will be gone.
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Post by lurker on Apr 24, 2018 22:26:22 GMT -5
What is the FEV1 part of if not the REMS? The plan of action (REMS) is no longer needed because it is completed. The FEV1 and all the other requirements are still in place since they were not part of the REMS. The REMS itself and the material making it up is in this link - Afrezza REMS. Look at the goals of the REMS. |
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Post by mango on Apr 24, 2018 22:28:23 GMT -5
What is the fev1 part of? The plan of action (REMS) is no longer needed because it is completed. The FEV1 and all the other requirements are still in place since they were not part of the REMS. The REMS itself and the material making it up is in this link - Afrezza REMS. Look at the goals of the REMS. That would be number 4 right here, the 4th Goal of the Afrezza REMS to be exact. 4. Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA. Spirometry is no longer required per the FDA. |
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Post by mango on Apr 24, 2018 22:36:26 GMT -5
AFREZZA REMS Goals:
1. Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease.
2. Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD.
3. Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease.
4. Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA.
Acute bronchospasm, COPD and screening for lung disease are no longer associated with Afrezza because the FDA has concluded that a REMS is no longer necessary. What does the Black Box Warning say? Exactly what is detailed in the REMS goals and is the STRATEGY for mitigating the potential RISKS identified in the REMS that NOW are NO LONGER required per the FDA.
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Post by mango on Apr 24, 2018 22:44:10 GMT -5
If informing healthcare providers of #1-4 is no longer required per the FDA, then how will healthcare providers know to do a spirometry? Oh right, the FDA just said they aren't required to.
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Post by mnholdem on Apr 25, 2018 4:53:31 GMT -5
Over the past few years we've all noticed how the Boxed WARNING has been front on center on every advertisement about Afrezza (some of you have even complained about it). That prominent warning was required because of the REMS. While the letter may not result in immediate removal of the Boxed WARNING on Afrezza, it does mean that MannKind can now change how Afrezza is advertised, which is welcomed news, IMHO.  |
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Post by BD on Apr 25, 2018 5:17:49 GMT -5
Now you know why there was so much short covering this past week, It’s also why the $2 calls were so active last week, The “in crowd” knew this news was coming. I was thinking the same thing, w/r/t all the activity last week--- and if the "in" crowd is actually "in the know" (as opposed to just INsiders getting the scoop) you'd think the buying was indicative of a belief the news would actually be a big positive for the company/stock. Unless, of course, it was perceived as presenting just another pump&dump trading opportunity... |
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Post by sportsrancho on Apr 25, 2018 6:25:09 GMT -5
Over the past few years we've all noticed how the Boxed WARNING has been front on center on every advertisement about Afrezza (some of you have even complained about it). That prominent warning was required because of the REMS. While the letter may not result in immediate removal of the Boxed WARNING on Afrezza, it does mean that MannKind can now change how Afrezza is advertised, which is welcomed news, IMHO. And it seems per website that they already have... |
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Post by matt on Apr 25, 2018 6:29:37 GMT -5
It is pretty clear from the letter that the REMS, which consisted of the communication plan, is no longer required. Since most of that is water under the bridge, the benefit is minimal but it is helpful nonetheless.
A change in the REMS requirements has no impact on the label copy so the black box remains. If a label change is approved, that will be a separate letter with a sample of the new label and package insert. Those are harder to obtain.
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Post by hellodolly on Apr 25, 2018 6:43:06 GMT -5
It is pretty clear from the letter that the REMS, which consisted of the communication plan, is no longer required. Since most of that is water under the bridge, the benefit is minimal but it is helpful nonetheless. A change in the REMS requirements has no impact on the label copy so the black box remains. If a label change is approved, that will be a separate letter with a sample of the new label and package insert. Those are harder to obtain. Matt, given the news of the most recent action by the FDA, would you think it likely that MNKD takes the next step (logical IMHO) to change the label or modify it in some other meaningful way? |
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Post by uvula on Apr 25, 2018 6:54:42 GMT -5
I've learned that when agedhippie and matt agree, they are almost always correct. The news is good but not huge. Spirometry remains. Black box remains.
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Post by hellodolly on Apr 25, 2018 7:43:49 GMT -5
I've learned that when agedhippie and matt agree, they are almost always correct. The news is good but not huge. Spirometry remains. Black box remains. While I agree with your assessment, there will be more certainty and additional clarification from MNKD, as to their interpretation. I hope they give us more color on their direction from this point, i.e.; modifications to the label, etc. in today's PR. |
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