|
|
Post by slugworth008 on Jan 29, 2016 13:28:46 GMT -5
I do expect that there will be one major disappointment coming out of the conference call.
I fully expect for CEO Matt Pfeffer to explain to shareholders that there are certain actions which MannKind Corporation cannot yet implement or even speak about before control of Afrezza is fully returned to MannKind Corporation by Sanofi. Like it or not, MannKind remains contractually bound to an Agreement which gave Sanofi 100% of the decision-making authority on virtually everything related to the marketing and development of Afrezza.
I expect Matt will explain that this restriction, that prevents them from carrying out or even discussing plans for development activities related to Afrezza (a mandate of silence that has been imposed by Sanofi for the past 1-1/2 years), must continue until the effective date of termination (EDT).
Like it or not, Sanofi has the legal right to impose two more months of preventing Matt from talking about pricing, insurance, marketing, trials or management's plan for launching international sales of Afrezza. Contractually, Sanofi retains sole control of these activities until the EDT and there isn't a damn thing we can do about it.
I suspect that this will undoubtedly be the biggest disappointment to come out of MannKind's upcoming investors conference and that CEO Pfeffer will take a lot of crap for it from shareholders who are tired of silence. Wall Street pundits will continue publishing harsh and negative articles, taking advantage of this situation.
I'm very encouraged by CEO Pfeffer taking significant steps to make MannKind Corporation become much more transparent for its shareholders, yet I fear that any news about Afrezza will continue to be subjected to negative press for another couple months. 
Good fortune all.
While I don't expect this - I would like to hear that SNY has allowed MNKD to regain complete control of Afrezza as soon as possible. As in as soon as an amendment to the existing contract can be finalized and signed. Wishful thinking on my part I know. |
|
|
|
Post by matt on Jan 29, 2016 13:32:23 GMT -5
That has two issues. First, if RLS siphons off valuable IP it does nothing for Mannkind or its shareholders as the value goes to RLS. If it is not a pure giveaway, the upsides belong to Mannkind and become part of the bankruptcy estate (i.e. the benefit goes to the creditors). Secondly, if the IP is transferred for demonstrably less than fair consideration, then the bankruptcy court can void the transfer as a fraudulent conveyance.
Friendly deals are permitted, but it cannot be friendly to the extent that it benefits the shareholders at the expense of creditors. Based on what we know, I think RLS is a typical deal for a drug delivery technology and does not benefit either party in an unusual way. Hence my comment, this does not protect Mannkind's patents in an significant way should bankruptcy occur.
|
|
|
|
Post by peppy on Jan 29, 2016 13:37:32 GMT -5
So, why allow bankruptcy to occur. (In regard to the post above)
Sell Afrezza.
License out technosphere.
---------------------------
Also would like to hear other thoughts.
|
|
|
|
Post by yossarian on Jan 29, 2016 13:56:22 GMT -5
If Matt says what you suggest, the stock will tank some more. MNKD does NOT have the financial wherewithal to wait the 6 months before it is totally free of Sanofi before taking corrective action.
|
|
|
|
Post by mnholdem on Jan 29, 2016 14:01:42 GMT -5
They only need wait until April 4. According to the internal memo sent by a Sanofi VP to their sales reps, that is the effective termination date, the date when the rights to market & develop Afrezza will be returned to MannKind Corporation.
We're only going to have to wait eight weeks (90 days after notice) rather than six months (180 days after notice) which would be the maximum that Sanofi can retain control according to the agreement.
I think I'll forward the question to Matt, asking him if Sanofi has established an official effective termination date. |
|
|
|
Post by esstan2001 on Jan 29, 2016 14:19:02 GMT -5
...
I think I'll forward the question to Matt, asking him if Sanofi has established an official effective termination date. of if it can be expedited sooner. :-) |
|
|
|
Post by lorcan458 on Jan 29, 2016 14:27:53 GMT -5
The question to ask is "You've said you want to lower the price of Afrezza to be in line with injectables. Has Sanofi prevented this from happening, are they continuing to prevent it and if so, what are you doing about it?"
I doubt Sanofi would block it. Not worth the potential violation of providing commercially reasonable efforts to promote Afrezza, which they already have done as demonstrated by comparison with their efforts in the Truejo launch.
|
|
|
|
Post by peppy on Jan 29, 2016 14:50:15 GMT -5
If I was working a intensive care unit and had diabetic patients, and we were running Continuous glucose monitors and the physicians were ordering afrezza and we could see the corrective action, there would be no doubt the continuous glucose monitor tells the whole story. If I know this every diabetic franchise and all big pharma can see this as well.
Because technosphere insulin has lung delivery, we are aware of lung delivery.
The break through in Hyaline membrane disease came in the 1980's. Babies born with hyaline membrane disease were given surfactant through the endo tracheal tube. You had to be working in an neonatal intensive care to see the difference.
Interesting gig the effectiveness of afrezza is right before our eyes, 
|
|
|
|
Post by peppy on Jan 29, 2016 15:12:24 GMT -5
|
|
|
|
Post by agedhippie on Jan 29, 2016 15:13:16 GMT -5
If I was working a intensive care unit and had diabetic patients, and we were running Continuous glucose monitors and the physicians were ordering afrezza and we could see the corrective action, there would be no doubt the continuous glucose monitor tells the whole story. If I know this every diabetic franchise and all big pharma can see this as well. An ICU would use an insulin IV since the patient will have line (probably a central line) already in. Also the patients are often usually sedated so they are not going to be in a state to inhale insulin (my brother is an ICU team leader  ). They use finger sticks to test levels rather than a CGM. |
|
|
|
Post by peppy on Jan 29, 2016 15:21:29 GMT -5
If I was working a intensive care unit and had diabetic patients, and we were running Continuous glucose monitors and the physicians were ordering afrezza and we could see the corrective action, there would be no doubt the continuous glucose monitor tells the whole story. If I know this every diabetic franchise and all big pharma can see this as well. An ICU would use an insulin IV since the patient will have line (probably a central line) already in. Also the patients are often usually sedated so they are not going to be in a state to inhale insulin (my brother is an ICU team leader ). They use finger sticks to test levels rather than a CGM. yes, blood sugars finger prick. The glucose and or heparin in the line has to be cleared before the central line is used for a blood glucose. Giving iv insulin requires a pump. A chargable item, yes. A pain to hang. A pain to keep track of. Anyway, those units are used to a lot of monitors. and alarms. as well as laboratory orders and results, and witnesses.
|
|
|
|
Post by dooberxl on Feb 1, 2016 18:04:53 GMT -5
An ICU would use an insulin IV since the patient will have line (probably a central line) already in. Also the patients are often usually sedated so they are not going to be in a state to inhale insulin (my brother is an ICU team leader ). They use finger sticks to test levels rather than a CGM. yes, blood sugars finger prick. The glucose and or heparin in the line has to be cleared before the central line is used for a blood glucose. Giving iv insulin requires a pump. A chargable item, yes. A pain to hang. A pain to keep track of. Anyway, those units are used to a lot of monitors. and alarms. as well as laboratory orders and results, and witnesses.
Current guidelines for ICU patients recommend maintaining blood glucose levels in the 140-180mg/dL range. This has show to provide lower incidences of hypoglycemia and improved mortality compared to intensive insulin control regimens. An insulin drip is preferred in this case due to the fact that the insulin is provided as an IV with immediate onset of action and a half life of ~10-12 minutes. This also allows a rapid titration and fine tuning of insulin / glucose levels to a desired target range. Yes, an insulin bag is a "pain" to hang and monitor, but keep in mind many ICU patients already have several lines (or a few multi-lumen lines) running, potentially with multiple vasopressors, antibiotics, and fluids running at once. This is why you (usually) have a 1:1 nursing ratio and a team monitoring the patient. Moreover, Afrezza is a rapid acting mealtime insulin. A majority of patients in an ICU are not fed enterally or parentally before being extubated / stepped down (with the exception of TPN's, usually after several days of an ICU admission). Enteral feedings that afrezza would be useful in due to the rapid peak of serum glucose levels post feeding are not common since a TPN is provided as a continuous feed. Therefore, a continuous insulin infusion is appropriate to cover this method of feeding or continuous tube feeds. Plus, how would one administer and titrate afrezza in an intubated patient? Not to mention the potential for drug binding to the intubation tube itself - leading to huge variations in dose provided. Afrezza is not appropriate in an ICU setting. |
|
|
|
Post by me on Feb 1, 2016 18:40:13 GMT -5
I'm with you od The board is getting out of hand lately; even people I normally respect are posting wide-eyed ideas. It's beginning to sound like YMB - which I thought you all were trying to escape. So everyone, please let's keep it real. If you're going to post some outrageous MNKD valuation, you need to at least give your time frame and reasoning. Failure to adhere to this will get your post deleted. Don't you think you're taking this board a little too seriously? This is still an anonymous on line message board for small time retail investors (me included). None of us sit on the board of directors here... , so because none of us sit the BOD, it's OK if we post BS, outrageous valuations and bogus theories?! Really?! Is that because no one here, unless they sit on the BOD, can possibly formulate any adult line of reasoning, and we are all only capable of the BS that goes on over at YMB?! Seriously?! You seem to be uncomfortable that the moderators wish this to be a more serious investor board. Are there ways that the moderators can make this any less serious that would be more in line with what you're looking for? |
|
|
|
Post by mnholdem on Feb 1, 2016 18:53:12 GMT -5
Frankly, I would be delighted if we could just manage to stay on topic, which is "what might happen at the Feb 3 conference call". This thread has been hi-jacked from the conference call ideas to the ICU then on to the Boardroom. Could we return to discussing the upcoming conference call for a while? Please?
|
|
|
|
Post by dreamboatcruise on Feb 1, 2016 18:55:33 GMT -5
Frankly, I would be delighted if we could just manage to stay on topic, which is "what might happen at the Feb 3 conference call". This thread has been hi-jacked from the conference call ideas to the ICU then on to the Boardroom. Could we return to discussing the upcoming conference call for a while? Please? Aren't we all hoping Dr. Matt tells us the patient has been upgraded from critical to stable  |
|
). They use finger sticks to test levels rather than a CGM.
