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Post by silentbob on Jun 27, 2014 17:01:50 GMT -5
This was a fitting end to a long string of nasty surprises, with all the confusion while the stock should have been halted for a few hours. I hope none of you guys were tricked out of shares!
I had a really short look at the label and PR, and have only a few comments for now:
- The boxed label is unfortunate mostly because it's an attention grabber. What is actually in it is rather benign. We already expected these contraindications, and a FEV1 test is a 5-minute test that can be performed by any GP/PCP. Contrast this trivial test with the hassle of getting a diabetic on injected insulin for the first time, with all the finger pricking and carb counting, and doctors will have a MUCH easier time prescribing Afrezza instead. However, the warning and test can and will be used by the shorts to continue their scaremongering until we can actually demonstrate sales.
- The biggest negative to me is that Mannkind seems to have abandoned the "Ultra Rapid Acting" description and has now switched to "Rapid Acting", making it harder for us to differentiate versus the much slower injected RAA's. I have no idea what would be required for Mannkind to be allowed to call it Ultra Rapid Acting.
- The hypo benefits didn't make it to the label either, a bummer but partially expected. I would expect at least the hypo trial results in there though.
- The biggest positive to me is that it seems an insulin naive patient can be started on Afrezza with just the minimal dose being prescribed without any need for carb counting. The dose will be increased next visit if it was insufficient. This means prescribing Afrezza to an insulin naive patient is a walk in the park and will be much easier for any GP/PCP to do vs prescribing injected RAA. I believe this convenience for the primary care physicians will give us a really big advantage.
I am sure that the benefits that didn't make it on the label will be all over the diabetes forums once patients get some hands on experience. Afrezza will sell itself for sure.
Now lets look towards a record breaking partnership!
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Post by Deleted on Jun 27, 2014 17:05:14 GMT -5
Congratulations to everyone!
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Post by ashiwi on Jun 27, 2014 17:12:38 GMT -5
Finally, Absolutely great news! That's why we need a strong marketing partner to educate the docs about the real benefits of Afrezza.
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Post by silentbob on Jun 27, 2014 17:13:32 GMT -5
- The hypo benefits didn't make it to the label either, a bummer but partially expected. I would expect at least the hypo trial results in there though. In fact the label further demonstrates that the FDA is not our friend. They included in the label the result of the placebo controlled type2 trial where Afrezza had higher hypos then placebo (duh), but completely omitted all the trial results where Afrezza had MUCH lower hypos versus ANY injected insulin. I am glad it is now out of their incompetent hands and Mannkind will get their chance to prove themselves in the market. Congrats to the Mannkind team!
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Post by alcc on Jun 27, 2014 17:26:06 GMT -5
- The hypo benefits didn't make it to the label either, a bummer but partially expected. I would expect at least the hypo trial results in there though. In fact the label further demonstrates that the FDA is not our friend. They included in the label the result of the placebo controlled type2 trial where Afrezza had higher hypos then placebo (duh), but completely omitted all the trial results where Afrezza had MUCH lower hypos versus ANY injected insulin. I am glad it is now out of their incompetent hands and Mannkind will get their chance to prove themselves in the market. Congrats to the Mannkind team! Indeed, FDA is (still) not our friend. Thank god for the adcom vote. Not sure we'd be here were it up to the agency alone. The fine print omissions (fewer hypos) on the label probably do not matter. Detailing will fill that in. I agree company should position drug as "new, ultra-rapid acting inhaled..." You think they were shot down by FDA approval re making that claim? The PK/PD in the label supports this.
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Post by spiro on Jun 27, 2014 18:29:27 GMT -5
Congratulations to all longs, the fat lady is finally off the stage and will never get to sing on this one. Wow, what a crazy day. I am still trying to digest what happened. I turned my computer on at 3:40, just in time for the brutal last 15 minutes of trading. I didn't know anything until I saw Liane's post about FDA approval. I told my wife and we both did a little Greek dance around my desk. I went back to the computer screen and saw the price plunging. I bought 30 more Jan 2015, $7 calls for $2.30. I am anxiously awaiting more opinions from real doctors about the label. Spiro believes the label is a damn good start and will not be too difficult for MNKD and it's partner to work with.
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Post by liane on Jun 27, 2014 18:36:43 GMT -5
So spiro,
Is the ouzo flowing freely?
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Post by lynn on Jun 27, 2014 18:37:41 GMT -5
It's a GREAT day for MANKIND as well as Mannkind !!! I wish I could see years into the future when the entire Technosphere platform is realized !! Imagine the possibilities .....
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Post by goodby1 on Jun 27, 2014 18:50:18 GMT -5
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Post by goodby1 on Jun 27, 2014 19:00:55 GMT -5
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Post by liane on Jun 27, 2014 19:09:02 GMT -5
ABC only mentions T2.
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Post by indigodaisy on Jun 27, 2014 20:02:27 GMT -5
OMG what a day!!!! I quick checked the stock price this afternoon and saw it had dropped over a dollar, and I panicked. I was like oh no, what happened. Then I went to the boards and someone posted in the subject line "Bad Label". I finally digested the fact that we got approved and it didn't matter now what anyone says to try to manipulate the stock. WE GOT APPROVED! It is now out of the hands of the FDA and out of the hands of the shorts and into the hands of Mannkind! Go Al Mann and Go Mannkind!!!!! Congratulations to all who never gave up!!!
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Post by liane on Jun 27, 2014 20:17:09 GMT -5
It is now out of the hands of the FDA and out of the hands of the shorts and into the hands of Mannkind! Go Al Mann and Go Mannkind!!!!! Congratulations to all who never gave up!!! Yes, still many hurdles, but MNKD is in charge of their own destiny now.
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Post by silentbob on Jun 28, 2014 16:45:07 GMT -5
The fine print omissions (fewer hypos) on the label probably do not matter. Detailing will fill that in. I agree company should position drug as "new, ultra-rapid acting inhaled..." You think they were shot down by FDA approval re making that claim? The PK/PD in the label supports this. If the FDA didn't prohibit it, I'm sure Mannkind would have preferred to keep using "Ultra Rapid Acting". Why else would they have abandoned this description? In the label the FDA claims the pharmaco dynamics (PD) are comparable because the "onset of activity" is comparable to Lispro. This means they believe that the two insulins have comparable PD because they START lowering glucose at the same time, completely ignoring PEAK glucose lowering and duration of effect, which are both much lower for Afrezza and a much more important aspect of the PD profile, as these influence the hypo rate and the shutdown of gluconeogenesis in the liver. Over time Mannkind will probably do more studies to improve the label in this regard. This ties into the ignorance of the FDA reviewers with respect to diabetes - remember how they suggested increasing the insulin dosage in the RAA arms and how the ADCOM panel members shot that down with a very astute "you just killed my patients" (paraphrased)? Let us hope the FDA does not remain this ignorant.
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Post by silentbob on Jun 28, 2014 16:53:01 GMT -5
Another omission that proves the FDA is not our friend can be seen in the FEV1 explanation and graphics.
All the trials have shown that the small reduction in FEV1 was completely reversible after stopping Afrezza usage. This was measured in the followup visits and was very clear in Mannkind's graphics.
The FDA completely ignored this important qualifier and even stripped it from the graph.
Why do they want to keep the facts hidden?
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