Amy is FUD. How insulting to her readers. What... Her A1c improvement can be tweeted but no actual data.....and she tells them its private? If her diabetes was private then we wouldn't know of her.
To her followers she is exclusively a diabetic.
What a phony
“ Change of Control ” means the occurrence of any of the following events from and after the Issue Date:
(i) the acquisition by any “ person ”, including any syndicate or group deemed to be a “person” under Section 13(d)(3) of the Exchange Act is or becomes the “ beneficial owner ” (as defined in Rule 13d-3 under the Exchange Act) of the beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of transactions of shares of the Company’s Capital Stock entitling that person to exercise 50% or more of the total voting power of all shares of the Company’s Voting Stock, other than (x) any acquisition by the Company, any Subsidiary or any of the Company’s employee benefit plans; (y) any acquisition during the lifetime of Mann by Mann or his estate, by any trust where Mann is the trustee or grantor, by any not-for-profit entity where the acquisition is directed by Mann or by any entity wholly-owned by Mann or his estate; provided that the total beneficial ownership of all such Persons, together with the Persons in (z), does not exceed 70% or more of the total voting power of all shares of the Company’s Voting Stock; and (z) any acquisition by any Person so long as the shares acquired by such Person are acquired directly from one of the Persons listed in (y) and no consideration is paid in connection with such acquisition;
(ii) the Company (A) recapitalizes, reclassifies or changes the Common Stock (other than changes resulting from a subdivision or combination) as a result of which the Common Stock would be converted into, or exchanged for, stock, other securities, other property or assets or (B) exchanges its shares of Common Stock with, consolidates with, or merges with or into, another Person or any Person exchanges its shares of common stock with, consolidates or merges with or into the Company, or (C) conveys, transfers, sells, leases or otherwise disposes of all or substantially all of its properties and assets to another Person, in each case other than (x) any transaction pursuant to which holders of the Company’s Capital Stock immediately prior to the transaction have the entitlement to exercise, directly or indirectly, 50% or more of the total voting power of all shares of the Voting Stock of the continuing or surviving entity of such transaction; or (y) any merger solely for the purpose of changing the Company’s jurisdiction of incorporation and resulting in a reclassification, conversion or exchange of outstanding shares of Common Stock solely into shares of common stock of the surviving entity traded or quoted on a U.S. national securities exchange, and as a result of such merger the Notes become convertible into such shares; or
(iii) the Company’s stockholders approve a plan of liquidation or dissolution.
Notwithstanding anything to the contrary set forth herein, a Change of Control will be deemed not to have occurred if, in the case of a merger or consolidation, at least 90% of the consideration (excluding cash payments for fractional shares and cash payments pursuant to dissenters’ appraisal rights) in a transaction or transactions otherwise constituting a Change of Control consists of shares of common stock or American depository receipts traded or quoted on a U.S. national securities exchange, or which will be so traded or quoted when issued or exchanged in connection with the transaction or transactions, and as a result of the transaction or transactions the Notes become convertible solely into such consideration.
SNY knows that once the SAFETY of Afrezza is established, the comfort level of prescribers will grow and it will be an easy point of scientific fact that prandial insulin makes sense as a first line addition to Type 2 orals (and may eventually prove to be a first line treatment vs orals?).
Everybody discounts the convenience issue, but it is exactly the 'discomfort' issue that has led to poor control of diabetes in this country. These patients 'should' have been started on prandial injections ever since that 2003 study was released.
The inconvenience of multiple prandial injections at the onset of treatment has led to a tremendous healthcare burden throughout the world resulting from suboptimal basal adjunctive therapy as a matter of convenience of a single injection.
The relative contribution of postprandial glucose excursions is predominant in fairly controlled patients, whereas the contribution of fasting hyperglycemia increases gradually with diabetes worsening. Monnier 2003 landmark study
Sentiment: Strong Buy
PRESENTED AT American Diabetes Association 71st Scientific Sessions 2011
Type 2 diabetes mellitus commonly affects elderly patients: more than 25% of US residents aged 65 years or older have diabetes, compared with ~10% in the total adult US population. Past studies have found that postprandial hyperglycemia (PPHG) makes a greater contribution to overall hyperglycemia in patients with type 2 diabetes who have good glycemic control, compared with those who have poor glycemic control. The objective of this study was to investigate how basal and postprandial hyperglycemia contribute to the total hyperglycemic exposure in elderly versus younger patients with type 2 diabetes.
The contribution of basal hyperglycemia to total hyperglycemia was greater in both elderly (aged over 65) and younger patients (aged 65 and younger) at baseline (poor glycemic control), but not after 24 weeks of diabetes therapy (good glycemic control). However, in elderly patients the contribution of basal hyperglycemia to total hyperglycemia was smaller than in younger patients, both at baseline and after 24 weeks. The difference in relative contribution of basal and postprandial hyperglycemia to overall hyperglycemia in elderly and younger patients with type 2 diabetes may indicate that different treatment strategies should be considered, depending on a patient’s age.
I almost forgot the convenience issue. Tell me that most of you took it for granted as well.
Did the high fat ice-cream slow absorption? Did the Cane Sugar found in ROW coke improve the outcome vs high-fructose corn syrup?
Despite the likelihood that both are true, this guy's blood glucose stayed below 108........
disagree. SNY knows what they are doing. MNKD has no money. What would it actually cost to get the $150m by now. I would guess a lot more than $25m on a credit facility.
Right now the goal for SNY is to get a vocal user base of 20k patients and take their success and data to insurers for better coverage. I believe that is exactly what they are doing.
While SNY might be willing to spend $100m to get the drug out there quickly, MNKD is not in a position to do so.
The exact same would be true with another partner because MNKD would still not have the money to spend.
SNY understands that carefully launching the product safely will mean BIG BIG sales down the road with an altered label and, more importantly, the confidence of prescribers.
Anyone who doesn't think the spirometry issue or a change of delivery system are huge doesn't understand the world of ENDO's. People who enter this field tend to be conservative NOT RISK TAKERS. They are not going to be the FIRST one out there and they need time and data from their peers who did take that Afrezza leap.
Yes there will be an impact at the primary care level eventually and there may be a few out there knee deep in Afrezza now, but insurers are going to discount their experiences vs that of endo's.
Why should we pay if Endos who specialize in the treatment of this disease don't write it?
You have to also appreciate that the culture of the drug rep is not alive and kicking...rather it's dying a slow death. So many products nowadays are not covered or superfluous to the regimen rather than providing clear benefits....Afrezza has benefits but only trials can change that.
At what point does BP look at a MNKD buyout offer if only to hurt SNY?
When Afrezza becomes a mainstream drug there will be many patented BP drugs taking a big share hit in the diabetes market.
It might make a lot of sense for one or two BPs to make a substantial offer to MNKD for its 35% stake and TS forcing a decision out of SNY. Do they not pay and risk BPs on the joint committee and let somebody else take hold of the Afrezza production? or do they pay and take 100% of everybody's money including market share from other BPs.
As Afrezza starts to get better coverage and wider usage, you can be there will be a few CEOs willing to make SNY commit if only to make SNY overpay.
The market is dying from boredom more than anything else. Slow and steady SNY was the perfect partner for cash poor MNKD. It was in the interests of both parties to NOT spend too much money at first and take credit line losses......2 quarters and we have used $25m dollars of a $175m credit line. We have produced enough Afrezza for 3 more months at the current Rx rate....(if not 6 months).
We have 3 lines that don't have any significant demand for more than 1.
Yes the 12U will help a little bit, but the insurers are going to reign it in a bit before they commit and they are gathering the utilization/cost data from these patients in order to further their coverage ambitions.
Let me ask you a different question.....where are the bad reviews? notice how you can't seem to find that many out there. we have seen about 100 people on the net who actually use afrezza talking it up (twitter/fb)
aren't you a bit surprised that we aren't seeing ANY negative comments.
WS has been playing rope a dope with the stock,
Nate Pile alluded to that great scene in the movie Colors when Duvall tells Penn the joke about the Bulls and Cows.
Young Bull says to Elder Bull 'why don't we run down the hill and f one of those cows?'
To which the Elder Bull responds 'why don't we Walk down and f them ALL'
SNY is going to get a strong price from the insurers if they can show success, and if social media is any indication, the convenience and efficacy speak volumes about what kind of a monster drug Afrezza can and will be.
Not particularly. Who would? I would rather see that than utilization of credit facilities at this time.
MNKD needs the cash. Afrezza will eventually pick up and since expectations at this point are at the absolute lowest for near term growth, any news that SNY has negotiated better coverage (and we are at 6 months from launch) would drive the longterm models higher. Any news that Europe and ROW countries are approving Afrezza will drive the stock as it furthers the long view of SNY commitment.
WS about to take us on a lightning run.
There will not be TV ads this year....Matt said so. They are obviously more concerned with getting 10-20k patients on the drug safely and smoothly and will allow them to tweet away while they collect data for the insurers.
Afrezza is a monster game changing drug and insurers need to be reassured of its safety and its need before they authorize better coverage.
By the time the followup studies alter the label, Afrezza will be covered everywhere including medicaid/medicare.