And in the meantime, MNKD steadily accumulates debt under that 175 million dollar loan facility that SNY FORCES it to use to pay its share of losses.
So it would be best to sell MNKD NOW and just WAIT until those docs have gotten "enough clinical experience" and see how much debt has accumulated by then?
I couldn't help but notice you didn't provide any reference to support the alleged "benefits" of c-pulse to the pulmonary circulation nor to exactly WHAT the "latter population" consists of. What can I say but HAW!
The past three weeks of declining new scripts might be a hint as to how much they're doing. Moreover, in reality, they probably can't do much. They can't provide spirometers to the docs, and there are plenty of reasons why docs don't want to mess with spirometry that SNY can't overcome.
I think the reason is that they BOTH know that the fat lady is singing for afrezza, so why sweat a problem that won't exist in six months.
The "majority of the patients...type 1"??? And you can document this how? Moreover, SNY has consistently said it is targeting type 2 diabetics. At least ONE reason for that is afrezza is NOT a good prandial insulin for type 1s BECAUSE it CAN'T be titrated.
I'm sure endos look at "trial information" and that's why I'm SURE endos aren't going to use afrezza as a prandial fast insulin in type 1s.
Script counts are low because, indeed, the market does NOT need it and, obviously enough, does NOT particularly want it. If there was a serious need or desire for afrezza, script counts would be MUCH higher. Afrezza isn't even doing HALF the business exubera did and exubera had that idiotic "bong" to overcome!
"If you outstrip capacity..."??? Uhhhhhh...build more lines? Build a new factory if need be -- I'm sure Danbury would be tickled to have a big pharma locate a plant there.
And of course they don't "need" to be the sole manufacturer. Indeed, why isn't SNY the manufacturer -- sole or otherwise?
No, what you're "dealing with" is the FDA specifying that afrezza is ONLY "non-inferior" to humalog and it's ONLY advantage is being able to avoid needles. Although they MAY point to the PK graph and show the rapid, early peak of afrezza, SNY can make NO claim to superiority in afrezza's effect. Beyond that the only ground on which to compete is price. SNY can't work miracles. They have to work within those restrictions.
And the endo is correct when he says that you can't titrate inhalable insulin. The simple fact that there's 10U on insulin in every 4U dose of afrezza tells you that. Although the AVERAGE amount reaching the patient may be SOMEWHERE around 4U, you have NO WAY of being sure EXACTLY how much they're getting. That's the main reason endos will likely NEVER use afrezza for type 1 diabetics.
I dunno, this sounds pretty reasonable to me:
"Now to sucker in money from the public, Mann took his company MannKind public, like Second Sight Inc (Nasdaq:EYES), to sucker in people's hard earned cash and retirement savings to fund his dog and pony shows."
Let's face it -- who is the ONE person who has made out like a bandit over the years with MNKD stock and debt?
Neither of the trials SNY is running will demonstrate superiority to humalog in actually treating diabetes. To do that would require something like SNY's "A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)" which is enrolling 3300 patients.
"Why doesn't he intervene..."??? Uhhhhhhhhhh...because he's read the writing on the wall and knows the "jig's up"?
HAW! I just noticed yet ANOTHER stupid thing! It says "the high prevalence of pulmonary hypertension in the latter population"! WHAT "latter population"? I don't see any "latter population"! Does anyone else see a "latter population" anywhere?
Does ANYBODY bother to PROOFREAD this tripe to see if it is at least GRAMMATICALLY correct?
"...working on their Pfizer insulin...??? I understand that, but why the OBLIGATION to buy 200 million dollars worth (that's what the agreement called for given the exchange rates at that time) over four years? Why not just buy it as needed or just obligate for a year at a time.
And why isn't SNY providing the insulin? SNY currently sells a huge amount of insulin in the US. I have a hard time believing they would need to do much more than make a phone call to the FDA for approval to provide insulin to MNKD.
Hospital pharmacists don't decide what to stock, they simply respond to physicians' orders. If the docs don't order it, it doesn't get stocked.
As far as SNY, you have to appreciate the HUGE barrier they have to deal with. Afrezza has been declared ONLY non-inferior to humalog. The ONLY selling point SNY has to work with is afrezza's inhalability as a means of avoiding injections. SNY reps can't make ANY other claims beyond that.
You think that's bad? Consider the 150 give or take million dollars of insulin that MNKD MUST buy from a French pharmaceutical company. Right now, exchange rates have been moving in a direction favorable to MNKD. But a weakening dollar could send that cost who knows how high. I still haven't figured out why that was part of the deal.
IF it were a "milestone," why not announce completion as such? More importantly, why announce it AFTER they've disappointed so many with the 100 million bond refinancing. Getting a significant milestone payment surely would have made for a better refinancing.
No, I think the announcement was just a pre-earnings "pump" to help take the sting out of what they likely expect will be a serious disappointment.
No, the huge mistake was made when Al decided to develop afrezza in the first place, but didn't recognize the costs and challenges involved, and, more importantly, didn't realize that diabetics were not all that interested in inhalable insulin. I think it turned into an "ego trip" for him -- a "cherry" on his successful life as an entrepreneur. He caved into the SNY deal deal probably because he realized he didn't have much time left to see his "dream" come true.
"MannKind's move to increase manufacturing capability is very important and should help bring clarity to what is happening."??? Seriously? Has ANYTHING that's been happening helped bring "clarity" to ANYTHING? In particular, how does the move to increase manufacturing bring anything? For all you know, MNKD did it just so they could announce it and help "pump" the stock before the earnings report.
I think more significant was the interview with Brandicourt -- transcript on SNY site -- and the fact that HE didn't mention afrezza. He played an important role in exubera's development and launch, and you'd think he express SOMETHING about afrezza and what he thinks of its potential. Not saying anything makes it look like he's already erased it from memory.