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Post by pengiep on Jul 19, 2016 12:45:49 GMT -5
I could see MNKD being reluctant to rely on the FDA considering any of their actions in good faith, given FDA's historical and potentially corrupt cooperation with MNKD's enemies.
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Post by sweedee79 on Jul 19, 2016 13:51:19 GMT -5
I bailed on MNKD last March intending to wait and watch. I re-entered today once it broke under $1. The single biggest reason I re-entered was the clamp study which definitively shows both the rapid in and rapid out quality of Afrezza. Even though most people who follow MNKD with any attention already know about this, the company has been hamstrung by not being able to speak of it. There are many articles now about it, word has to be circulating amongst the endo population and others. We have a leading doctor in the field (Dr. Kowalski) definitively stating "The drug is simply astounding". These are very tangible and verifiable aspects that did not exist previously - almost all the eye-popping results were from current users and open to the "yes, but they are biased and how do we know they are telling the truth?" argument. I'm very impressed with Mike Castagna - I think Matt made a stellar choice there. There seems to be a coherent and effective plan to move forward and of course Afrezza is just as good as it has always been. I might regret the decision to re-enter but I just feel optimistic that things are heading the right direction and the company has some mojo. T he clamp study is key - now there is published, easily verifiable evidence of clear superiority. Although not on the label -yet - it is still a quantum leap over the only other previously published information which of course was the clinical trial data showing only non-inferiority. I think that is huge and will be a factor in convincing both doctors and patients who were previously on the fence. Hate to be a wet blanket, but the clamp study does nothing to refute the non-inferior clinical trial results. MNKD still has to show that the speed advantage results in actual outcomes that matter (eg. lowering A1C, lower hypos, etc.). I think Mike's intent is that FDA will allow the label to say "faster", and that will enable the reps to convince more docs to give it a try. That's the slow, grinding one-patient-at-a-time process we're stuck with without convincing superiority data, but the PK/PD becomes the hook. I think a time-in-range study that Mike mentioned would be a big help, but I'm not sure it's even started yet. Sounds like an attempt to generate fresh superiority data will be done in the pediatric study first. Just add patience and money. Yes, the clamp study will be used to change the label to "ultra rapid acting insulin" ... but that is a big step. In and out of the body fast is important. Doctors understand the benefits of a faster acting insulin and it will in fact set us apart from the rest. The label changes will be done one step at a time.. maybe not as fast as we would like.. but there are many good things happening in the company that will attract attention to Afrezza.. there are many out there who know what Afrezza is and since we obviously aren't going down without a fight... many more will find the truth despite the hurdles we have yet to face .. are there any guarantees?? Of course not. The situation is what it is.. but it seems to me that Matt and Mike are giving it all that they have. |
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Post by myocat on Jul 19, 2016 14:05:13 GMT -5
"I bailed on MNKD last March intending to wait and watch. I re-entered today once it broke under $1. The single biggest reason I re-entered was the clamp study which definitively shows both the rapid in and rapid out quality of Afrezza. Even though most people who follow MNKD with any attention already know about this, the company has been hamstrung by not being able to speak of it. There are many articles now about it, word has to be circulating amongst the endo population and others. We have a leading doctor in the field (Dr. Kowalski) definitively stating "The drug is simply astounding". These are very tangible and verifiable aspects that did not exist previously - almost all the eye-popping results were from current users and open to the "yes, but they are biased and how do we know they are telling the truth?" argument. I'm very impressed with Mike Castagna - I think Matt made a stellar choice there. There seems to be a coherent and effective plan to move forward and of course Afrezza is just as good as it has always been. I might regret the decision to re-enter but I just feel optimistic that things are heading the right direction and the company has some mojo. The clamp study is key - now there is published, easily verifiable evidence of clear superiority. Although not on the label -yet - it is still a quantum leap over the only other previously published information which of course was the clinical trial data showing only non-inferiority. I think that is huge and will be a factor in convincing both doctors and patients who were previously on the fence. On a personal satisfaction level it also validates my "the laws of nature and statistics do not lie" mantra. I've always felt that ANY patient who tries Afrezza with proper titration should experience the same sort of benefit that we have seen so frequently by other users since monomeric insulin should work essentially the same way in any given human body. Now there is a scientifically valid study that demonstrates that precisely. The new sample packs should provide adequate time for titration so there is no reason that the vast majority of patients on the new sample packs will not be having this superior outcome and then be raving about THEIR results (thus creating the rapid growth curve investors have long hoped for). The 10 day packs used by Sanofi never came close to really unleashing this phenomenon and was a major reason for the slow uptake - in fact was probably detrimental since patients who quit probably told others they saw no benefit. I like the energy of the 2.0 team, the new sample pack strategy, the nurse educator desk, the call support, reimbursement assistance team, lots of things that seemed to be completely missing from the Sanofi debacle. Cash has been a concern as long as I have been around MNKD so nothing new there. There has to be an element of hoping for the best with this investment and I think Matt will find a way to get cash when push comes to shove. I'm feeling pretty good about the clamp study results and the new sample packs waiting to give the Afrezza miracle to lots and lots of new patients. Just my thoughts for whatever they may be worth. Sometimes it's nice to see something optimistic." I am reading the post as, "it's a good entry point and I am back in and i am pumping it" Just Kidding. |
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Post by daduke38 on Jul 19, 2016 15:19:43 GMT -5
dudley, great sentiments!! But, it sounds like after more than 100 days on the wagon, you have fallen off.  Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can! Do we all agree that the reps can legitimately sing the praises of the clamp study to the docs they visit? I believe they can, anyone out there think differently? It is my understanding that the reps cant push anything that isn't on the label... unless the docs specifically asks the rep for info on the clamp study..... I could be wrong but I don't think so.. if so our hands are still tied by the label, however, Matt stated at the last annual shareholder meeting that they would be seeking label changes yet this year, using the clamp study.. I don't know, but my experience in business and life for that matter, is a lot of info is exchanged "Off the Record". Hopefully our sales force has past relationships where they can give the REAL benefits. Anyone on here that claims they have never used the phrase " I didn't say this, but....." I wouldn't believe them. I'd give anything at this point to go through the resumes of our 60-70 person force. Think it would be very telling as to whether Mike can turn the tide or not. |
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Post by dudley on Jul 19, 2016 16:01:58 GMT -5
It is my understanding that the reps cant push anything that isn't on the label... unless the docs specifically asks the rep for info on the clamp study..... I could be wrong but I don't think so.. if so our hands are still tied by the label, however, Matt stated at the last annual shareholder meeting that they would be seeking label changes yet this year, using the clamp study.. I don't know, but my experience in business and life for that matter, is a lot of info is exchanged "Off the Record". Hopefully our sales force has past relationships where they can give the REAL benefits. Anyone on here that claims they have never used the phrase " I didn't say this, but....." I wouldn't believe them. I'd give anything at this point to go through the resumes of our 60-70 person force. Think it would be very telling as to whether Mike can turn the tide or not. Duke, the pedigree of Mike himself along with the VP's of marketing, and the salesforce appear of the highest quality coming from the biggest names in the business with tons of experience. All they have to focus on is ONE single product, no distractions. The product has been out for a year and a half now with no real negatives (no major adverse events of any sort) and virtually non-stop positives. Add in the new data (regardless of what naysayers like to trumpet, the clamp study is VERY significant and even if the reps can't use it in direct marketing it is THERE for all the diabetic universe to see. Anyone with the remotest interest can find it with the slightest degree of effort) and it would seem to me that selling Afrezza now should be much easier than the first run with Sanofi. None of this information was around, the launch seemed haphazardly directed and they got the sample packs wrong as well. Never any guarantees but in my mind it should be a much easier sell now and the new sample packs and all the corporate assistance should result in much better patient outcomes and subsequent retention. That's the source of my optimism and the rest of the picture remains the same - massive global market and the best performing insulin the world has ever seen. Sure I can lose a buck by re-entering but this is a legitimate 10-bagger or better IF the story plays out. They have the organization in place now to make it happen and they have been quite forthcoming with information. Compare now with the days of Hakan mumbling his way incoherently through conference calls and nobody being able to say anything because Sanofi had the gag orders in place. |
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Post by sportsrancho on Jul 19, 2016 16:41:03 GMT -5
It is my understanding that the reps cant push anything that isn't on the label... unless the docs specifically asks the rep for info on the clamp study..... I could be wrong but I don't think so.. if so our hands are still tied by the label, however, Matt stated at the last annual shareholder meeting that they would be seeking label changes yet this year, using the clamp study.. I don't know, but my experience in business and life for that matter, is a lot of info is exchanged "Off the Record". Hopefully our sales force has past relationships where they can give the REAL benefits. Anyone on here that claims they have never used the phrase " I didn't say this, but....." I wouldn't believe them. I'd give anything at this point to go through the resumes of our 60-70 person force. Think it would be very telling as to whether Mike can turn the tide or not. I didn't say this, but: I've been told by some doctors that that is indeed the case:-)). |
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Post by babaoriley on Jul 19, 2016 16:51:56 GMT -5
Of course, there will be much "off the record" conversation, especially if the rep has a good relationship with the doc. I just hope the reps available have good relationships with some docs!
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Post by mnholdem on Jul 19, 2016 18:47:46 GMT -5
Of course, there will be much "off the record" conversation, especially if the rep has a good relationship with the doc. I just hope the reps available have good relationships with some docs! I imagine that's the thinking behind Mike's hiring. I think he wrote/said that the majority of the newly hired sales reps have diabetes sales experience, with the balance having experience selling medical devices.  |
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Post by falconquest on Jul 19, 2016 20:01:13 GMT -5
I bailed on MNKD last March intending to wait and watch. I re-entered today once it broke under $1. The single biggest reason I re-entered was the clamp study which definitively shows both the rapid in and rapid out quality of Afrezza. Even though most people who follow MNKD with any attention already know about this, the company has been hamstrung by not being able to speak of it. There are many articles now about it, word has to be circulating amongst the endo population and others. We have a leading doctor in the field (Dr. Kowalski) definitively stating "The drug is simply astounding". These are very tangible and verifiable aspects that did not exist previously - almost all the eye-popping results were from current users and open to the "yes, but they are biased and how do we know they are telling the truth?" argument. I'm very impressed with Mike Castagna - I think Matt made a stellar choice there. There seems to be a coherent and effective plan to move forward and of course Afrezza is just as good as it has always been. I might regret the decision to re-enter but I just feel optimistic that things are heading the right direction and the company has some mojo. The clamp study is key - now there is published, easily verifiable evidence of clear superiority. Although not on the label -yet - it is still a quantum leap over the only other previously published information which of course was the clinical trial data showing only non-inferiority. I think that is huge and will be a factor in convincing both doctors and patients who were previously on the fence. On a personal satisfaction level it also validates my "the laws of nature and statistics do not lie" mantra. I've always felt that ANY patient who tries Afrezza with proper titration should experience the same sort of benefit that we have seen so frequently by other users since monomeric insulin should work essentially the same way in any given human body. Now there is a scientifically valid study that demonstrates that precisely. The new sample packs should provide adequate time for titration so there is no reason that the vast majority of patients on the new sample packs will not be having this superior outcome and then be raving about THEIR results (thus creating the rapid growth curve investors have long hoped for). The 10 day packs used by Sanofi never came close to really unleashing this phenomenon and was a major reason for the slow uptake - in fact was probably detrimental since patients who quit probably told others they saw no benefit. I like the energy of the 2.0 team, the new sample pack strategy, the nurse educator desk, the call support, reimbursement assistance team, lots of things that seemed to be completely missing from the Sanofi debacle. Cash has been a concern as long as I have been around MNKD so nothing new there. There has to be an element of hoping for the best with this investment and I think Matt will find a way to get cash when push comes to shove. I'm feeling pretty good about the clamp study results and the new sample packs waiting to give the Afrezza miracle to lots and lots of new patients. Just my thoughts for whatever they may be worth. Sometimes it's nice to see something optimistic. This stock is either one hell of a buy at this price or an example of throwing good money after bad. My sense is, it is a great buy opportunity but after all we have been through who wants to hang their hat on that? I wish I had more confidence I would buy like a madman right now. |
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Post by prolux on Jul 20, 2016 8:19:39 GMT -5
I feel the need to set you all straight on this point with respect to what sales reps can and can't state to health practitioners. Following AMRN's landmark court victory, the FDA has wisely modified their stance with respect to the information which can be used to market FDA approved products. In AMRN's case, they can now market a drug approved for a different indication (Trigs above 500) to doctors for use in patients with Trigs between 200-500 because they have a clinical trial study result which demonstrates the efficacy of the drug for that population. MNKD and every other drug company can do the same. If their statements are true and within the context of the published trial results, then it is free game, protected by the First Ammendment. Look into it a bit for a deeper understanding as I'm only scratching the surface here in the interest of time and accuracy.
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Post by mnkdfann on Jul 20, 2016 9:11:09 GMT -5
I feel the need to set you all straight on this point with respect to what sales reps can and can't state to health practitioners. Following AMRN's landmark court victory, the FDA has wisely modified their stance with respect to the information which can be used to market FDA approved products. In AMRN's case, they can now market a drug approved for a different indication (Trigs above 500) to doctors for use in patients with Trigs between 200-500 because they have a clinical trial study result which demonstrates the efficacy of the drug for that population. MNKD and every other drug company can do the same. If their statements are true and within the context of the published trial results, then it is free game, protected by the First Ammendment. Look into it a bit for a deeper understanding as I'm only scratching the surface here in the interest of time and accuracy. "The FDA downplayed the significance of the settlement. "It is important to note that this settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech," the agency said in a statement, Reuters reports." David Rosen [Amarin's lawyer], who spent 14 years with the FDA and is now an attorney with Foley & Lardner in Washington, DC, told FiercePharma today that he expects companies will start pushing in this. But he said he will advise them to be "very cautious in engaging in off-label promotion," because what constitutes truthful and not misleading remains a very gray area. "It is still not expressly clear where the line is," Rosen said." |
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Post by prolux on Jul 20, 2016 10:44:46 GMT -5
LOL, do you think that the FDA wants to lose in court again ? No, they won't challenge further. They may continue to play back office politics by slow playing the interests of entities which they feel are not properly aligned, but challenging them legally, they'd have to be plain stupid. They already got their asses handed to them in court - twice.
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Post by prolux on Jul 20, 2016 10:58:03 GMT -5
It may not signify the FDA's position on the First Ammendment and the Freedom of Speech, but who gives a sh^t ? The courts opinion has come through load and clear and that is what counts. The corruption at the FDA is rampant; PDUFA is the equivalent of letting the fox guard the henhouse, so they will no doubt continue to undermine those who are not part of the big pharma group which provides The large majority of the FDA's funding. After all, a bureaucrats first interest is in self-preservation. Public opinion and legal challenge is where the FDA remains vulnerable. They must be fought on that ground. Luckily, the court's interests happened to be aligned with the best interests of pharmaceutical companies and in my opinion, patients.
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Post by mnkdnewb on Aug 1, 2016 13:47:44 GMT -5
Thought about making a new thread, but this one is pretty close to my feelings now. Over the past month especially, I have pretty much been down in the dumps and really considering selling at a $68,000 loss (bought in at $2.87 on TASE day). My biggest worry was Mnkd going bankrupt soon. However, last week Saturday while mowing the lawn for about an hour, I started calculating some #'s in my head with how the sales team would do over the next year. After that, I busted out the calculator. IMHO, I think we will break even in about 1 1/2 years with u.s. Sales only - now, what I wasn't sure about was how to value the company once we break even. My estimate was about $1,300,000,000 without an international or domestic partner - what do you think???. I believe we will get some pretty decent partners before we break even, which would multiply that market cap by at least 2 or 3 especially if we received some upfront cash. This mornings announcement really boosted my confidence and I can't imagine the high level executives they've signed on this year would leave their cozy jobs for a dying company - even if th y receive stock options (wouldn't be worth anything if Mnkd bankrupts). I know there will be at least one more fund raise / dilution, but I think that is already priced into the current share price. I told myself I would sell if I wouldn't have been willing to buy at a certain price (I went against that rule about 3 times now). After last week Saturday's "epiphany" and today's news, I think I would have bought this morning. I'm feeling ok right now and am aware we are still a few months off before we see a decent uptick in s.p. Finally smiling again |
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Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can!
