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Post by tayl5 on Aug 11, 2015 9:38:04 GMT -5
tayl5,
I don't understand your #1. The Aug 2015 notes must be converted in one of three ways: exchange for 2018 Notes, MNKD Shares-for-Notes or Cash. #2 & #3 are among those choices, but how does the note holder buying shares in the open market result in a return of their notes, which expire August 15? My comments refer only to the exchange of notes for shares, i.e. conversion. The idea behind #1 would be that the holder buys the shares in advance of the repayment with other cash, then uses the cash that comes in from the payment to restock the treasury. Of course, it could also work that the holder collects the cash and then uses it to buy shares on the open market if they remain low. Apologies for my lack of clarity. |
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Post by peppy on Aug 11, 2015 9:55:30 GMT -5
MannKind's (MNKD) CEO Hakan Edstrom on Q2 2015 Results - Earnings Call Transcript
seekingalpha.com/article/3423816-mannkinds-mnkd-ceo-hakan-edstrom-on-q2-2015-results-earnings-call-transcript
First, the pediatric study protocol has been approved and will begin screening patients by September of this year, as all vendor and site contracts will be finalized this month. The second study on dose range is now fully enrolled and the trials are expected to complete in the first quarter of 2016.
The third study on within-subject variability is underway and subject dosing should be completed in the fourth quarter of 2015. The protocol for the fourth and final study on the five-year pulmonary safety received comments and recommendations back on the FDA in July, which are now being reviewed by the joint Sanofi and MannKind clinical team. Discussions are expected to be held with the reviewing division of the FDA to further clarify their recommendations and provide our comments back. That study is planned to begin in early 2016. So, in summary, we are pleased to note that the strong progress has been made in meeting the FDA post-marketing study requirements for Afrezza. And we note that Sanofi continues to support the partnership by coordinating and leading all efforts in this key ongoing activity.
Total and new prescriptions show consistent month-over-month growth.
Importantly, Afrezza data is being published in peer-reviewed journals and getting in front of physicians. Both of our recent Phase 3 pivotal studies 171 and 175 have now been published electronically in diabetes care with print versions to follow.
But insurance coverage continues to slow the process. At this point, permanent formulary placement decisions have not yet been made by most plants. These decisions are typically made 6 to 12 months following the launch. The good news is that, we are now in that period, and Sanofi’s discussions with managed care organizations are ongoing, and we expect the insurance coverage and patient access to improve.
Our program in pulmonary hypertension has entered the technical feasibility phase, during which we prepared for the dry powders and evaluated their aerodynamic properties, stability, and other characteristics. We expect these activities will take about six months or so, before we will have powders that can be evaluated in animal models.
The pain management program is focused on the product that is intended to manage moderate-to-severe acute pain and is also in the technical feasibility phase. We have already prepared several prototype powders to formulate around a small number of active pharmaceutical ingredients or API, and we have evaluated some in preclinical models. The results have been actually very encouraging so far. The focus now is to select the optimal API and move to Investigational New Drug or IND-enabling studies.
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