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Post by vissertrades on Jul 20, 2014 8:21:00 GMT -5
Troy on September 30th, 2010 12:38 am
Afrezza
No hypoglycemic events in all cases even when you eat nothing if used alone in a small study. Experts say it might be halting the progression of the diesease.
No carbohydrate counting
No dialy titration
No weight gain
No pulmonary issues
No lung function issues
No shot
No side effects except a slight cough in a few that subsides, and a slight risk of a hypoglycemic event when using Afrezza with a basil insulin and the basil is suspect for the cause
Superior Hyperglycemic controls to the gold standard of care
Superior Glycemic controls to the standard of care
comparible H1A1c’s
To be Tier II insured
There are currently 285 Million diabetics in the world growing to 430 million by 2030
Now I imagine they will be paying $1,500~ each for a year supply to $2,000~ (guessing) still
lets do the math… what is 285million X 2000 equal? and that is every year and growing to 430 million over the life of the patent..globally..
and that is just Afrezza! Mannkind has a Monopoly on inhaled insulin!
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Deleted
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Post by Deleted on Jul 21, 2014 12:50:31 GMT -5
Hi there That's an interesting old posting, but interesting only because it shows the impact that the P3 trials and label have had. This post will draw some heat, but it shouldn't. The original post should instead be corrected, because our understanding of Afrezza has evolved. The company can now only legally make maybe one of those claims. If this post makes you irritated, ask yourself why. Is it because I'm being rude by taking a position counter to a soothing, encouraging post? If so, then add "cures erectile dysfunstion" to the list of benefits. But of course you can't because Afrezza hasn't proven that benefit. Thing is, according to the P3 trials and label, they haven't proven this list either. It's why there wasn't a huge price pop on approval. The "weight advantage or weight neutral" "hypoglycemic advantage" "HbA1c advantage 0f 0.5 - 1.0 should be a low bar" talk was not borne out. Afrezza is a mild and convenient insulin, plain and simple. That should be enough to build a good customer base, but the claims below were not supported. P3 trials showed this claim to be in error. Hypoglycemia listed as a side effect. And why noy? It's insulin, after all. Nope - T1s especially will still have to count carbs, titrate and correct BG. Again not the case. Weight gain is a side effect Small decrease in lung function; risk of bronchospasm in some sub-populations See above T1s will have to use SC basal, as will T2s if physicians keep to the ADA standard of care (no reason to think they won't) Affinity 2 showed that even in absence of basal, Afrezza has a risk of causing hypo No - SC insulin can be titrated more agressively to bring down BG (and as a result HbA1c) See above SC Insulin brings down HbA1c more than Afrezza. That is not known yet There are currently 285 Million diabetics in the world growing to 430 million by 2030 Now I imagine they will be paying $1,500~ each for a year supply to $2,000~ (guessing) still lets do the math… what is 285million X 2000 equal? and that is every year and growing to 430 million over the life of the patent..globally.. and that is just Afrezza! Mannkind has a Monopoly on inhaled insulin! Read more: mnkd.proboards.com/thread/1023/nice-afrezza-summary-2010#ixzz387q7olE5 |
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Post by babaoriley on Jul 21, 2014 15:16:21 GMT -5
"It's why there wasn't a huge price pop on approval."
Derek, I won't argue the various points you make (I think many of them are somewhat in the gray part of the spectrum, and one could argue either way); however, the above-quoted statement, well, how do you explain the rise from $4 the day before Adcom to $11 the day after approval? Once AdCom came in so overwhelmingly (not "mildly and conveniently") in favor of Afrezza, most felt the FDA approval was in the bag, and that was the reason there was only a small pop on approval, which small pop has since faded. You did a lot of work for most all of your post, I found your conclusion about the price not popping interesting in light of the care you obviously took otherwise.
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Post by rak5555 on Jul 21, 2014 15:22:55 GMT -5
Derek, your post provides a rational explanation for why the share price has not appreciated the way longs had hoped following approval. My belief is that MNKD and/or their partner/acquirer will conduct additional studies designed specifically to modify the label over time such that they will eventually be able to make most of the claims outlined in September 2010 (at least those where the market opportunity justifies the cost of the study). Imagine the PR as each of these studies are concluded and new additional market share is opened up.
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Post by savzak on Jul 21, 2014 16:00:57 GMT -5
I agree with rak. Perhaps as importantly, I also think good old fashioned user experience will go a long way toward proving up many of these points even before such studies are begun. The docs will be getting first hand feedback from the early adopters which will convince them of the facts long before the additional studies are completed. To a large extent, those studies will only confirm the conclusions the users and their doctors will by then have already reached.
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Post by vissertrades on Jul 21, 2014 16:05:54 GMT -5
Didnt they build a bridge to all previous testing with 171/175 trials? if so, didn't those studies show some of the benefits mentioned?
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Post by spiro on Jul 21, 2014 17:00:28 GMT -5
MNKD has come a long way since 2010, with both type 1 and type 2 getting approved. We all agree the label needs a lot box work, but most new drug labels usually do. IMO, the right partner will make Afrezza a strong selling drug in several years. I will stick with the endo's at the AdCom and the various docs that post here regarding the need for Afrezza as a new weapon to fight diabetes.
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Post by Deleted on Jul 21, 2014 17:02:30 GMT -5
Thanks for the friendly replies, folks.
Hi vissertrades. The bridge to previous trials was for FEV1 tracking (pulmonary safety). Affinity 1 and 2 trials were used for approval, and determine what MNKD can claim.
Perhaps the post-marketing studies will show some of the listed benefits. But perhaps not. That will be for the trial design and trial data to determine.
Babaoreiley - the share price action you speak of was in the pre-approval runup, with plenty of volatility through Adcom. Since approval, there has been no pop. Boy do I wish there had been, but the market decides, not me. You have to admit that you're cherry picking time frame there as well, quoting the day's low from the pre-Adcom bear raid. A more representative range would be $6.20 or so in the week before Adcom - $10.50 - $11.00 during the week of the surprise approval announcement. A good runup, but not because of the label, since the label wasn't known, and the label, now that it is known, has not kept the share price up (hope for a large pharma partner is , IMO). Of course, I could simply be incorrect in my attribution as well, and the price action could be for other reasons.
Rak & Savzak, good points. I think the fullness of time will tell on that. Robust results could expand label which would be great, and word of mouth / testimonial could be powerful.
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Post by spiro on Jul 21, 2014 18:55:44 GMT -5
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Post by mannmade on Jul 21, 2014 19:02:50 GMT -5
Thank you dereklinders for your post in an intelligent and reasoned manner. Though i may not agree with some of it, at least you supported your conclusions and also did not take the road of unproven McCarthyistic conspiracy theories and brash statements with no foundation nor did you bash anyone at Mannkind for no reason... So welcome...
I can understand some doubt about many items you reference and some need to be taken on a bit of faith until proven or disproven, but based on the testimony of the diabetics at ad com, the testimony of the head of the endocrinologist society, and more recently the head of the ADA I think we are, with the right partner, going to see a nice rise in share price. (This assumes as I have stated in earlier posts that terms of the deal upfront and ongoing are perceived by the market as good and that the right tone is taken in the press release... and lastly the launch is not delayed)
having said the above I also agree with baba about price being built in with ad com. Not that long ago that we were sitting in mid 5's and then down to high 3's day before ad com.
Lastly, even though many speak about it's existence as material to the stock price, I do not think the value of technosphere has been priced in to the stock yet. And I honestly think this is because most are truly limiting their focus to Afrezza (as it should be at the moment) and that until a deal is done for a technosphere license we will not really know the value of the opportunity.
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Post by babaoriley on Jul 21, 2014 19:37:39 GMT -5
I'll give you another, unpopular reason the price did not pop on actual approval - all the darn dilution over the years due to the FDA and MNKD not seeing eye to eye on what was required. We got up over $4 billion in market cap, that's a good bit of change for a company without am apparently needed partner. We also have a very active and large short colony which pulled every trick they could to try to keep a lid on the price.
Those who thought we were going to shoot up to $13-$15 or more right away with partnershipless approval, what did they have? Emotion. Heart. Loyalty. Good things to have, but sometimes expensive to maintain!
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Post by mannmade on Jul 22, 2014 12:36:29 GMT -5
I also have another thought about all this discussion of what Afrezza can and can't do... based on the last Phase 3's. I recall someone saying from Mannkind that they ultimately may have done themselves a disservice in the original design of the studies... The reason I recall this was being said was that after two crl's they did not want to risk a third and therefore designed the studies intentionally with the lowest threshold they believed required for approval by the FDA, which they got.
So it stands to reason there would be some doubt and room for discussion on how good (or great) Afrezza may possibly be at this stage and it also explains all he testing post approval the FDA is requiring (which for the most part I am in agreement with).
As a result of this set of facts, I have chosen to look at the testimony of the Afrezza Users/Diabetics who testified at Ad Com, the head of the Endocrinologists Society and more recently the head of the ADA and give their statements a more heavily weighted emphasis in my predictions for the future of Afrezza and Mannkind...
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