I am perfectly comfortable about the situation. Why should mnkd release anything about the launch and give competitors a heads up? Having been privy to several new product launches in consumer products, this is par for the course until competitors get ahold of launch info from sales materials and the like. I suggest everyone relax and enjoy the remainder of the holidays. jmho
Happy New Year!
Of course it matters. If you haven't seen the movie The Imitation Game I suggest you go see it. You'll see what role advance information can play in mounting a competitive attack.
Mann will get his splash launch - in due time - and I am sure he already knows about it and has approved it. I believe there will be a strong retail consumer component of this launch and that requires as much secrecy as is possible until it is ready to go.
How do you know they are hiring? As a long, I would like to see proof before believing. I'd like to know that I am holding for legitimate reasons.
I wasn't able to talk in depth about Afrezza given the setting but she had heard of it and knew, without my prompting her, that it was made by Mannkind. She said that she wished someone from the company would talk to her about it and explain it more. So....my takeaway is that awareness of Afrezza is beginning to build but, as expected, reps have not yet covered all doctors, if any, at this point in time. I expect that sell-in along with physician coverage will ramp up soon now that the holidays are behind us. Stay tuned.
How can launch be one month away when no one knows when launch is going to be other than first quarter. That said, your name alone earns you an ignore.
Agree with everything you say. FWIW this doctor practices in Westchester County, an upscale are just outside of NYC. I expect this will be an area of focus for the launch. We shall see.
Data not that old - especially since diabetes management drugs/ platforms have not changed that much in 3-4 years. It would seem to me that Afrezza's cartridge delivery would be especially helpful in keeping track of dosage amounts for the elderly.
IMO MNKD will not release projections until they have actual sell-in numbers and need to give earnings guidance. Forget SNY doing that - sell-in will be buried in their other revenue numbers. They will not reveal their strategy except in broad strokes, which we already know. Large pharma accounts MAY be given a minimum ballpark advertising spend needed to justify SNY's sell-in quantity recommendations to those accounts, but the only way to get those will be through competitive intelligence (i.e accounts leaking info to competitors which does happen). In my opinion there will be no press release with regard to advertising spend or creative content. These are all my opinion based on experience in two consumer products companies, both owned by big pharma. Long and strong. Good luck all - and may it be a very Happy New Year for all mnkd longs.
Though I have read through the entire piece, the following paragraph written by the author (calls himself a clinician but I am highly skeptical) says it all to me.
"I don't work for the Cochrane Group, and since I'm not at work, I don't have ready access to online resources to review the literature up close and personal. But I did have access to ClinicalTrials.gov, and doing a quick search for "Afrezza" brought up a total of 58 clinical trials, most of which don't have any results yet or only include Exubera as a study medication (more on that in a second). Out of curiosity, I tabulated some of the raw data from these trials. I included only trials that listed change from baseline A1C as a primary or secondary outcome, and also limited myself to those studies involving Afrezza (not Exubera). Trials without available data were excluded, as were studies focusing on pharmacokinetics that did not look at A1C change. The review generated 9 studies for inclusion for analysis:"
So the author looks at 58 clinical trials "most of which don't have any results yet." Are you kidding me?! That says it all to me- a totally worthless article.
In addition, his "conclusions" are based on raw data. Totally worthless again. Without statistical analysis results are totally meaningless.
Finally, I am beginning to wonder how old this piece of trash actually is. He claims not to have "access to online resources to review the literature up close and personal." Really? I seem to recall pouring through the most recent study submitted to the FDA (a huge document) that I easily accessed online. I spent the entire weekend pre-AdCom going through the results which looked pretty conclusive to me.
I also find it hard to believe a clinician who should have extensive background looking at clinical data would waste so much time on incomplete data and post it on the rag that SA IS.
More hogwash from SA - JMHO.
In general I agree with you. However, I believe one has to respond to those that disseminate false or inaccurate information that can impact an investor's decision to buy or sell the stock. Despite all of the BS from bashers, I have learned a lot from post on this board.
Sentiment: Strong Buy
This is a copy and paste from the approval:
Afrezza (insulin human) inhalation
4 units – 6 cartridges per day 8 units – 9 cartridges per day
Prior Authorization of Benefits
Requests for Afrezza (insulin human) may be approved if the following criteria are met (either I, II, or III) AND (IV, V, and VI):
I. Individual has been on the Afrezza (insulin human) in the previous 180 days; OR
II. Individual has had a previous trial of one preferred rapid‐acting insulin (Novolog or
Humalog) in the previous 180 days.; OR
III. Individual is requesting Afrezza and is unable or unwilling to administer injectable insulin.
IV. Individual is 18 years of age or older; AND
V. Individual has a diagnosis of diabetes mellitus and one of the following:
a. For type 1 diabetes, individual will be using concurrently with long‐acting insulin;
b. For type 2 diabetes, individual has inadequate control, intolerance, or
contraindication to at least 2 oral anti‐diabetic medications;
VI. Individual has had a physical examination including detailed medical history to identify
potential lung disease.
Afrezza (insulin human) may not be approved for the following:
I. Individuals with a diagnosis of chronic lung disease, such as asthma or chronic obstructive pulmonary disease; OR
II. Individuals who smoke cigarettes or who recently (within 6 months) quit smoking; OR
III. As a treatment for diabetic ketoacidosis.
Note: Afrezza (insulin human) has a black box warning for the risk of acute bronchospasm in individuals with chronic lung disease. Afrezza is contraindicated in individuals with chronic lung disease such as asthma or COPD. Acute bronchospasm has been observed in these individuals. Before initiating therapy, a detailed medical history, physical exam, and spirometry (FEV1) should be performed to identify potential lung disease.
I don't interpret it that way. In fact I think it covers all the bases. Best of all is is III where individual can be prescribed if they request Afrezza as long as they have been diagnosed with diabetes. Note all of the "OR"s throughout the criteria.