Are the long term holders concerned

[dstevenson]

Link to blog

May 1, 2015 15:38:17 GMT -5 gomnkd said:

The stock is without support right now. It is like a worm on a hot deck, with birds circling. Many longs will go through fear, panic
and capitulation. We are only seeing fear emerge.

(Fugacity's blood is boiling now and is going to go apeshit on me. But Wait)

After capitulation, shorts will cover. We'll see a sharp rally that'll catch everyone by surprise. Months of losses will be erased in a few days.

Even though MNKD mismanaged a few things, Al Mann had put so much capital and often times at prices above the prevailing market price.He could have put debt and taken co. through bankruptcy wiping out common. He didn't. At partnership time, he would have seen and agreed to their marketing plan. I still have faith in Al Mann. Whatever he promised about Afrezza is shown to be true now. His explanation about A1C was spot on (he hand wrote and faxed me his thoughts that I posted to my blog).

I'm sitting on big losses which will surely get bigger. I predicted it and still didn't trade. For me this is the time to hold if you believe in the product. If you don't you should sell and move on. This is baptism by fire, and if your conviction is made of wax, it'll melt.

OK, now I made Fugacity & others happy.

[savzak]

May 1, 2015 15:38:17 GMT -5 gomnkd said:

apeshit

A great word from my past. It's amazing what becomes nostalgic.

[kball]

I haven't been invested even a year yet so i may not be experiencing as much pain as some (on price), but if given the choice of A) a drug being better than advertised w a slower launch vs B) a quick launch and wider adoption but lower efficacy with unforeseen side effects...
I would prefer the former as a longer term hold.

Sometime patience rewards the thoughtful and less nimble.
But not always.

[gomnkd]

May 1, 2015 15:43:12 GMT -5 dstevenson said:

Link to blog

afresa.blogspot.com/2010/06/prandial-insulins-effect-on-hba1c.html

The A1C issue was the biggest hurdle for me to overcome. Pt's are showing non-diabetic values (based on correlation, we'll see in 3 mo's). Docs go by A1C.
-------------------------------------------------------------------------------------------------------------------------------------------------------------
In 1992 the results of the NIH sponsored DCCT study correlated HbA1c to three major long-term complications of diabetes, and since then the goal in therapy has been to reduce HbA1c to as close as possible to normal levels (~5.7%). Because of the difficulties of achieving that goal the usual targets are 7.0% for the ADA and 6.5% for most other expert societies.

The long-term complications of diabetes can be devastating, but short-term hypoglycemia is also serious and can result in coma and even death. It is estimated that about 8% of Type 1 diabetics die of hypoglycemic incidents. The challenge in diabetes therapy is to balance long term safety issues with short-term safety issues.

With today's prandial products, insulin persists and is present in the body long after the meal is already digested. This excessive insulin persistence without counter-balancing glucose leads to a late postprandial drop far below baseline (i.e. below the level before the meal/injection). To reduce this short-term safety risk of hypoglycemia patients are managed at high fasting glucose levels. The basal insulin dose is lowered in practice to increase the fasting glucose. These high fasting levels increase HbA1c and also mask the advantages of a superior prandial (mealtime) insulin. That is why trials with AFREZZATM do not usually result in a better HbA1c. Let me explain:

HbA1c is essentially an approximate measure of a person's average glucose levels over about three months. The correlation of HbA1 c to estimated average glucose (eAG) is as follows:

HbA1c (%)   eAG (mg/dl)
5                  97
6                  126
7                  154
8                  183
9                  212
10                240
11                269

To see the effect of this let us look at a recent study in which the cohort using insulin Lispro (HumalogTM) had an almost unchanged HbA1c over the life of the study, with an average 7.62% at the start and 7.61% at the end. These HbA1c’s would translate into an estimated average glucose level of 171.8 mg/dl. Yet the fasting glucose level was 178mg/dl so the average glucose level over those few months was actually lower than baseline. How is that possible?

The explanation is simple. If the late postprandial reduction in glucose is larger than the prandial increase for the meal, the average glucose can actually be below baseline. An ultra-fast acting Insulin that does not have that persistent hyperinsulinemia would not have the late postprandial plunge and would thus have a higher average glucose and of course a higher HbA1c.

Indeed, if there were an absolutely perfect prandial insulin that has zero excursions- no highs and no lows --- no matter what a person eats, in the trial cited above the HbA1c would have been higher because the eAG would have been 178, not 172 mg/dl.

That is what I tried to convey in my presentation at the Merrill Lynch Conference. The fasting glucose level in study 009 in type 1 diabetes was 188 mg/dl and the HbA1c improvement was less than for the insulin Lispro arm and, because of the data spread, the upper 95% Ancova confidence level was .38% or .401% depending on the statistical methodology. The FDA limit for non-inferiority, i.e equivalency, is .400%. In its Complete Response Letter (CRL) the FDA specifically indicated it was not asking for new trials but invited us to present further analysis of existing data and new data to support the non-inferiority of AFREZZA compared to insulin Lispro.

We have in fact responded to the Agency with both additional analysis of our earlier data and new data in type 1, especially from Study 117, in which HbA1c for AFREZZA was a tiny bit better than for insulin lispro.

Since in Study 009 the HbA1c for AFREZZA was not better than for insulin lispro and since HbA1c is today’s measure of efficacy, why should anyone use AFREZZA? First, I am convinced that AFREZZA is certainly a better prandial insulin that more closely matches typical meal digestion. Only with such insulin that does not exhibit late postprandial hyperinsulinemia can fasting glucose levels be reduced enough to enable people to safely reach a normal HbA1c. Secondly, AFREZZA is clearly better in all the other important secondary measures. It has less risk in hypoglycemia (even though this is also partially masked by the insulin glargine (LantusTM) basal dosing) and also there is less weight gain --- usually weight loss. For AFREZZA to reach better HbA1c’s compared to current injectable insulin, physicians must recognize that AFREZZA itself does not cause the hyperinsulinemia so that they will be more comfortable in reducing fasting levels safely to near normal.

I believe that even in type 1 diabetes AFREZZA will become recognized as the superior prandial insulin that does not itself lead to hyperglycemia, lowers postprandial highs, is weight neutral, does not need complex meal titration, does not require multiple daily finger sticks, and is more convenient and discreet in prandial therapy. Certainly we cannot make such claims based on the registration trials to date. Interestingly, about 15 years ago, based on the registration trials, the FDA saw no benefits of insulin Lispro compared to regular insulin other than convenience in not having to take the injection 45-60 minutes before the meal. Today no one rationally questions that RAAs are superior in SC injections. It will require physicians and patients to become more comfortable with the better safety profile of AFREZZA in real world therapy before they will lower fasting levels that will support a claim of superiority in HbA1c for AFREZZA. I expect that will follow soon after several planned studies are published which I am certain from the science will establish the advantages of AFREZZA.

[Deleted]

Gomnkd, I lol'd

[gamblerjag]

Doubt there a BO in the works. Matt's response of seeing how Afrezza is received in q2 and q3 tells me that BO isn't happening anytime soon. JMO

[coco]

Disappointed yes, selling never. I will sell when Al sells. Just think about it Al put all this time and money in for what, a flop. I don't think so. Have patience everyone. Put this on the back burner a wait it out. Or not. Have a great weekend.

Coco

[s4cure]

Not that sny or mnkd didn't give you confidence. Can you list one thing they promised but failed to deliver? Your confidence was only eaten away by the price action.

You need to ask yourself if it makes sense to sell now at a valuation of 1.7 billion. Sny's milestone payments total 1 bil.

[Chris-C]

May 1, 2015 20:12:56 GMT -5 s4cure said:

Not that sny or mnkd didn't give you confidence. Can you list one thing they promised but failed to deliver? Your confidence was only eaten away by the price action.

You need to ask your self if it makes sense to sell now at a valuable of 1.7 billion. Sny's milestone payments total 1 bil.

I'm frankly amazed at some of the comments on this board by folks who declared themselves committed long investors in months past. It seems to me you either believe in the product or not. Nothing of substance has changed about the fundamentals. In fact, early adopters, if anything, are reporting eye catching results, validating Mr. Mann's observations of five years ago. That man has $1B (of his own fortune) and many years of dedication behind this stock. Plus, he's proven he is a successful entrepreneur. When he sells, I'll be concerned. Beware the fool who knows the cost of everything and the value of nothing. Cost (share price) does not equal value.
Chris

[_neil]

My god baba.. Here I am whining about the price you suspect I'm short? I'd be dancing in the streets if I really was. I got burned a couple years ago shorting a stock and I'm never getting into that again. My only investing options are going long or staying out. 
Anyways, I was trying to say this sector in general and this company in particular are clearly not for people like me. I will stick around and wait for my exit point. 

[lynn]

To each their own , but I just spent an hour + , catching up on threads from Diabetics on Afrezza ( I also follow them on twitter ) . I initially had regret about boarding this train before AdCom , Approval , Partnership ect as I could have gotten in at a much lower average now .

But now , I've no regrets about doing what I did . As it seems to be the latecomers who are questioning this investment ( as would I if I hadn't already spent 1000's of hours of due diligence ) . Tonight , after reading that blog ( some new some old to me ) my convictions are more solid than ever ( I'm aware of mgmnt silence ect , but trying to keep this short ,) )

The one thing I did do is cancel my (3rd limit buy order , each time lowering it ) . I chased it up & bought at $10 & I'm now willing to see how low it will go before I buy more . I'm sure I won't catch the bottom but if I can get more shares for my $ , with the shorts at the Helm , then so be it .

Selling hasn't crossed my mind & I've got more $ in this than I've ever put into any one thing in my 43 years on this Earth (& I've owned 2 condos , 1 in Denver , now 1 in SoCal ). Some may be looking for a quick return , this will require steadfast Patience ( normally not my strong suit ,))
and Faith in the advancement of Science . I AM IN

Have a great weekend

Lynn

[gamblerjag]

Very true. I think people are just more mad at the current stock price and that they bought higher;  because does it really matter if it was 7 earlier this year and one was  hoping for it to be 12 by end of the year.... compared to starting at 7 retreating to 4 then back to 12 by end of year..  so bottom line..  if the price gets to where longs expected it really doesn't matter where it goes in between.. right?   that' why I think many are just mad they pulled the trigger earlier this year..  me included at 5.90 and 5.45

[bioexec25]

Opportunity cost always weighs on me. Locking up so much capital for so long definitely makes me concerned. Especially when it seems with just a little effort by the wealthy off our money mgmt team the PPS could be at least supported while we wait. I haven't heard shareholder value mentioned even one time on any call or presentation. Very odd even for an inexperienced mgmt team. That implies corruption or gross incompetence.

GOOD NEWS imo is we are "in" on the ground floor near the bottom at a time when the market is frothy and corrections seem inevitable. Further in the grand scheme selling now would be like waiting days at the airport for a delayed flight and then leaving a few minutes before the flight finally departed. So other than very contrarian plays like BTU it is slim pickings out there in this market. I do want to echo the "hang in there" message by you good folks on this board. I believe we will all be much happier by July and will likely have some PPS support type news this month.

[bioexec25]

Ditto a post on YMB that I hope patients and docs aren't worried about starting on a therapy who's public value continues to plummet. May be hard to commit when at this rate bankruptcy seems likely to the untrained investors eye not to mention the large number of bashers doing their damage. Even if Mnkd or Sny doesn't give a rat's a## about us you would think s 60-70% pps loss since approval with no support in sight would cause them to inject some pace in getting the word out. I will wait it out like most here but I just don't buy they are doing all they can or should.

[kball]

Question for those who have held but bought at higher or much higher prices...
Anyone considering taking losses by selling to offset capital gains in other stocks and then buying MNKD back?

I'm in between 4.80 and 6.60 (multiple purchases) and am sitting tight.
Fear of missing a big sudden move up and Im more patient than most