"...said Pierre Chance..."??? Yeah, I bet! That "quote" came from last August at the announcement of the agreement. No doubt it was carefully worded by someone in public relations to match the event. Try googling what Chancel has said about afrezza since then. Then google "Chancel" and "toujeo" for just the past MONTH. What do you find?
It's called "obfuscation." At every turn MNKD either gets into some complicated deal that confuses the daylight out of anyone trying to understand it, and THEN they hide behind things like "we can't discuss blah, blah, because of terms of the contract " or "we can't discuss blah, blah because of we don't want to reveal anything to our competitors." It's taken a decade but they now have the "smoke and mirrors" and "dog and pony show" down to an art! Pfeffer is practically a "stockjobber" Van Gogh! All he needs to do now is cut off an ear!
Indeed, "the Danbury plant has only one production line with a capacity of 120 million Afrezza cartridges per year." My own very crude calculation figuring from reported revenues with each single dose costing around 50 cents, is that SNY has sold less than 10 million doses (and I'm being generous in my estimates) in six months. So I would say that the additional two lines won't be needed for quite some time to come.
Yeah! "Fool's Gold!? That's a laugh! Pyrite is at least worth SOMETHING for its iron content! So far afrezza has only been a near infinite supply of worthless RED INK!
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.