mnkd use the same dosing tactic with Afrezza, and insulin is a drug that has very narrow safety margin. For example, each breath gives max 10 units but variability may range somewhere around 2-10 units. Thus, someone who needs 8 units to be therapeeutic may only get 2 units. That's the reason why they couldn't get HbA1c lower than SubQ insulin, even though by theory Afrezza should lower HbA1c
BTW, alot of other drugs have wider safety margins than insulin, meaning that there is a wide range of dosing and it is still safe. Let's use motrim, since almost everyone is familiar with it and it's kidney toxic effect renders inhalation a big advantage in that the dose can be significantly reduced and still have quicker and similar pain control to oral form. In other words, pts with kidney problems can take inhalation motrim because the dose to relieve pain is smaller and action is quicker, yet still giving similar or even better pain relief.
That is just one example, there are many applications and you can find special uses for inhalation forms. Drugs that have wider safety margin should fly by the FDA, all they have to show is safety profiles and efficacy which shoud be quick and easy.
most other drugs have wider safety margins than insulin-- all they have to show is safety profiles and efficacy which should be determined within a few years of studies, not going to be 10 years like Afrezza.
For instance, you can inhale motrim for quicker response to pain and allows smaller dose and less impact on someone with kidney problems. Let's say, max dose that anyone can get from ONE puff is 200 mg but variability is between 20-200 mg each breath depending on patient's breaths. Drugs with wide saftey margins will sale like pancakes, no problem with FDA
there are hundreds, if not thousands, of drugs out in the market that have detrimental effect on the kidneys and liver from first pass metabolism. Hence patients with liver or kidney problems can not tolerate these drugs. Turn them into inhalations and bypass the liver. Inhaltion also allows smaller dose usage; therefore less toxic effect on the body and less impact on the ki.dneys metabolism which would benefit those with kidney problems greatly.
Mnkd is sitting on a delivery platform that has been approved by the FDA; greenfield work isn't done folks. Sanofi is just the beginning.
true, but part of that deal, they may also want to have access to technosphere. I just can't believe that a delivery powder that has been accepted already by FDA will not undergo other drugs platform for inhalation. Think about it, why would you sit with technosphere when there are hundreds of other applications. Mnkd can sell rights to other companies to use technosphere.
I am thinking Medtronic may ink a deal because they manufacture a lot of medical devices. Pfizer has alot of drugs that may be converted to inhalation for quicker response, or any drug that has detrimental impact on kidneys or liver can bypass these metabolic pathways where inhalation is more tolerable to the patients.
Amph for insulin
Sanofi for comercial and sales
The candidate to manufacture Dreamboat may also ink a deal for technosphere (Can't believe Greenfield was hired to just ink a simple deal with Sanofi; there has to be multiple deals).
Short days are numbered....that is all i can say at this point.
What?! you gotta be kiddin! that's $2.5 bil upfront pay. This may support my suspicion by management has been downplaying their success; there is always something not disclosed in these contracts.
I was actually thinking that Sanofi, depending on how Afreeza is perceived by the market during the first half of 2015, may offer Mankind a complete buyout by 2015. But your insight is much brighter.
I am repeating myself again, insiders intentional put effort to lower share price.
1) the 6 weeks silence after FDA approval
2) Only after such long silence they came up with $150 mil up front payment that seemed like they are givin away Afrezza for free.
3) You insulin storage comment where management could have easily said, "not FDA approved or certified but we are looking to get some certified and used in the future". But instead, he said, "could be bad, defective because it's so old"
When management should have pumped but they didn't and they put so many negative spins on their own company; it has to be intentional. The question is why?
That is my theory too. Buyout! I actually thought that management wasn't going to announce anything at the earnings conference. I predicted a speech that would go something like, " we are actively looking for partner and buyer, and we just need some more time to finalize our decison", and the stock would plumet ted, maybe more so than today. But that would have created a mob of angry investors and legal issue when they promised to have made their decision by 6 -8 weeks after FDA approval. Annoucing a partnership with Sanofi is more of a disguised. Thus Sanofi could buy everything, both technosphere and Afrezza. Or they could sell technosphere to a different company (less likely because Sanofi would still have to use technosphere.)
A. Mann sold all his prior projects, at 89 yo, I am shocked that he took on this partnership.
true but at the same time, everyone wants to protect their own pockets. Protect now is better protection in the future. If you read by first thread on this message, you would realize that we could be trading at above $20 at this moment, if management had done something like I suggested. Deceptive but still within legal rights.
My point is: when it looked that bad, it had to be intentional
that is the strange thing, Al Mann owned nearly all of that 47% insider shares. Why did he and along with his insiders who owned millions of shares hid in silence and watched their shares get destroyed after the biggest success in the company's history. To top it off, when they finally made their first announcement since FDA approval, the Sanofi initial pay was so low it almost seemed like they were giving away Afrezza for free. Clearly this was a setup because to be this bad you would have to put some effort into it. I have a theory but I want to hear what everyone else is thinking
It would only be logical for management to pump the stock after such an event, especially when they owned 47% of the shares. As long as you stay within the legal limits, you can lie and pump. If I was Al Mann I can call up my friend the Ceo of Merck, for example, and agree to a Merck buyout at let's say $8 bil. But I would also say, the decision wasn't finalized yet, it's still within legal limits to lie as long as I am ambiguous enough. The shares would have gotten pumped to $20/sh; shorts would have been torched mometarily. Then all of the sudden, I would say mnkd is more interested in a partner rather than a buyout and sign partner with Sanofi instead. At this point, investors would have been left with the impression that mnkd just turned down an $8 billion cash for bigger pay. Thye stock would probably rally even higher. than $20.
So instead, management staid silent, allowed shorts to rape the share price for 6 weeks. When it came to Sanofi deal, eventhough the deal is for $925 mils paid in installments but the initial pay was only $150 mil that it got investors spooked, and the shorts jumped on and raped the share price again. IT JUST DOESN'T MAKE SENSE. It seemed like management intentionally wants the share price down for whatever reason. That is the puzzle that I can't figure out. #$%$ is going on?
By the time the drug is out, pts will be asking for it.
they love needles
Instead of getting all at once, sanofi is paying off by installments by meeting milestones. $150 mil for starter and the rest comes w milestones, sanofi is just reducing their risk by exposing too much all once. Sanofi is paying almost all the expenses in sales, commercializing, studies, regulatory . All mnkd has to do is spend $30 mils a year on insulin and cheap inhalers, manufacturing is already built.
Those who sold got suckered because the way the broke up payments into installments. I wouldn't be surprised if this shoots up to 12-15 area tomorrow once investors realized what an awesome deal this was for mnkd, little or no expense and still owns technosphere w 35% profit from afrezza handled by best seller of diabetic drugs. Kramer is right for a change.
the way this stock traded for the last 6 weeks CAN NOT be a partner. I don't care what management said about getting a partner. Either buyout or nothing new is added to the CC this monday. So either a hammer is coming down on shorts who don't have insiders info or stock plumets to $6. Place your bets!
or management doesn't have anything at all, no buyout and no partner. So, your answer is either a buyout or nothing.