Will all that happened and the most probable conclusion that the FDA opinion was positive before the Shkreli mess, makes you wonder....hmmmm....if it looks like a duck, walks like a duck, it must be a duck.
However, a critical question is why switch inhalers ?
Does that indicate a lack or results with MedTone ?
Or, Does the Dreamboat delivery mechanism, higher efficiency, and reduced probability of cough support the switch. Mann smarter than we think......
I believe this is a $25 to $40 stock after top line results.
The delivery platform for Afrezza is the Dreamboat inhaler. Dreamboat is the second generation inhaler and MedTone was the first. Afrezza has received two CRLs (first and second) and both CRLs are due to the same flaws, which, by the way, are not related to the safety or efficacy of Afrezza.
The first CRL cited that Mannkind needed to prove the comparability between the MedTone inhaler used in clinical trials and, at the time, a new version of MedTone that would have been marketed. Similarly, the second CRL cited that a comparability test of the MedTone inhaler and Dreamboat inhaler was needed, as well as new clinical trials for the Dreamboat inhaler.
I think you could ascertain that the FDA although impressed with the function of Afrezza had a problem with the medtone inhaler. Al and mangement knew this and siezed the opportunity to use the next generation inhaler.If not for the whole invivo vs invitro comparison it would be a done deal!
What was the problem? The inhaler worked very well! It was designed to transfer powder from a blisterpack into the deep lung (alveolar) tissue were it works best. The problem IMHO is that it was desined as a multiple use product in which was dependent upon cleaning which may have proved problematic. You may ask what is the difference between medtone and a device like an asthma inhaler. Simple inhalers for asthma deliver to the bronchioles to have there desired effect. If an inhaler desinged to deliver to deep lung tissue were also efficicient in delivering bacteria, mold, spore etc into the deep lung what problems may arise. The solution is dreamboat!
Dream Boat inhaler uses 1/3rd as much technosphere. This reduces cost of care by 1/3rd while increasing their facility technosphere production by 1/3rd. Dreamboat is disposable after 2 weeks. It's 1/4th the size of medtone which again, cuts the cost again. Lastly, it delivers delivers technosphere much faster to the lung making it more effective.
BTW, this is not a $25+ stock after top line. After top line $5, before pdufa $7.50 and after approval $15.
agreed about $15 bucks.. some of these other guys (including and NOTHING AGAINST MANNKINDLY) but his post just gives predictions and he never acknowledges O/S - market cap or excpect revenues which we all know is usually what warrants a PPS. Just his one year timeline based on different scenarios.. There is nothing about this company that warrants at $35 pps or 15.5 billion dollar price tag.