"...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.
...about the "fully implantable" press release is that developing a working TETS would be REALLY big news for the company that did it. However, a visit to both Cirtec's and Minetronix's websites make NO mention of ANY TETS period! Must be bashful, huh?
And now that I think about it, what happened to the latest TWO cows that SSH was experimenting on? In the past they were always quick to brag about how well the "fully implantable' system did in their bovines, but they haven't said a thing about their most recent victims.
I only just noticed this line from the "fully implantable" press release:
"The benefits of C-pulse and counterpulsation on the pulmonary circulation and the high prevalence of pulmonary hypertension in the latter population may also provide for a therapeutic opportunity with a fully implantable system in this large population with an unmet need."
Uhhhhhhhhh...say what? Exactly WHAT "benefits" does c-pulse confer on the pulomanry circulation? Did I miss a publication because I sure can't find any that say massaging the aorta does squat for the pulmonary circulation.
This is another technique scam biotech companies use as more and more investors realize what a total failure the company REALLY is -- they start conjuring up "alternate" uses of their drugs or devices or whatever. So a failed cancer drug MIGHT show promise for treating hemorrhoids, etc, etc. Of course, they have dozens of reasons why this might be so, and, of course, they'll need more MONEY for further research and trials -- not to mention management's salaries, benefits, bonuses, and perks! You get the picture!
"controller"??? Who cares about the "controller"? It's the PUMP that sucks up most of the energy -- try blowing up a small balloon 70 times a minute and you'll soon discover what I mean.
Did you even notice the DATE they expected to do the first implant ? The THIRD quarter of 2016! Gee! So a week before earnings they "update" and announce "plans" for a first human fully implantable device OVER a YEAR ,from now?
Why? Why not announce something like that as part of a comprehensive update with the earnings release? Get over it already! The press release was just a pre-earnings "pump" to give bagholders something to hang their hopes on!
"Sanofi eventually manufacturing Afrezza"??? If that's true then why is MNKD expanding its production lines? Indeed, why doesn't SNY simply buy MNKD's production lines?
Actually THREE things -- the third being the simple fact that diabetics aren't all that interested in it.
Not only that, but is THAT the ONLY ad they got? What did they do -- budget for one homeless guy? And, geez,couldn't they have afforded to give him a shave!
Personally, I think "spiro" is as phoney as a three dollar bill. I reviewed his posts over at proboard and he had been pumping MNKD for at least a year before approval, and I couldn't find a single instance of his mentioning he had diabetes. Then come February of this year, he's SUDDENLY a type 2 diabetic whose doc has agreed to violate ALL standards of type 2 therapy and start this clown on afrezza!
Not only that but he starts him on a dose that likely wouldn't have ANY effect on an average type 2 diabetic!
And miracle of miracles, his fingersticks are near PERFECT! I mean we're talking 100 plus or minus 5 nearly EVERY time! JESUS couldn't get fingersticks as good as this character!
No, I think I'd want a notarized statement from his "PCP" detailing the "spiro" diabetic history before I'd believe ANYTHING he claimed.
Another likely pseudodiabetic is "afrezzaguy." His diabetic history as published on diabetesmine reeks of PHONEY! By the way, has anyone noticed that, just recently, "afrezzauser," "afrezzaguy," and I think at least one of the "afrezzuser" crew have started promoting Toujeo? Gee, what a coincidence, huh?
"... holding off on any marketing push until EU approval at which time they gain greater reward for their efforts."???? Well, given that they HAVEN'T yet applied for EU approval and have given NO indication when or even IF they plan on applying for EU approval, I don't think that's why they're "holding off on any marketing."
Also consider how dumb it would be to do such a thing. Most countries have socialized medicine and aren't likely to pay up for afrezza -- go back and review what the EU countries said when Pfizer tried to get exubera covered. It would be more rational to "fire all your guns" in the country where you at least have a shot at decent third party reimbursement. Not only do you have the chance to assess REAL consumer demand, but you have a chance for a "leg up" on reimbursement.
"SSH much more like pacemaker"??? Tell me which brand of pacemaker requires the user to lug around bag holding five pounds of batteries.
Over two years? Don't you mean over FIVE years? I mean, after all, Rosa said FOUR YEARS ago that he was lookijng forward to putting one in a human in 2012! What happened to THAT plan? How many cows did they fianlly kill since?
Like I said, if they got a working TETS, they should just dump c-pulse and market the TETS because it would likely be worth thousands of times more than ANY idiot aorta massager!
Right now it seems like they're letting it pretty darn quickly! No mention in SNY's conference, no mention in interview with SNY CEO -- just a dead tree waiting for a little push come January.