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Post by kc on Oct 18, 2017 9:00:44 GMT -5
10/17/17 Q: Mike C eluded to international expansion many times. Besides the upcoming filing in Brazil by Biomm, what are other expansions? UAE, Mexico, Canada? The later two and U.S. Are members of NAFTA, having no tariff, low cost of shipping thereby making Afrezza 25% cheaper in those countries. What are we waiting for? Oman is newly added also on the expansion map. Is it safe to say any expansion in USE will have nclude Oman, Saudi Arabia? A: We continue to update on our international expansion at every opportunity as it represents a means of expanding Afrezza sales, one of two top priorities expressed by both Mike and Steve, the other being recapitalization. As Mike stated in August, we are still on track to file by the end of the year in Brazil, if not sooner. As you may surmise, with the recent approved label update, our partner, BIOMM, wanted to reflect the FDA's approval in its filing with ANVISA. The timelines with respect to other international opportunities vary based on regulatory requirements in each country and potential partnership discussions always seem to take longer than originally anticipated. We are currently targeting Canada, Mexico, India and China in the near term and, as you know, after following MNKD all these years, we would not make any announcements until there is a definitive partnership agreement in place. UAE has always been an area which Al felt passionate about. We continue to work with international regulatory experts to prioritize our expansion. Q: When is the next ER? Please know that we are in our quiet period prior to our upcoming earnings call to be scheduled by or prior to the mandated 10-Q filing date of 11/9/17. As you may know, there is coordination required with executive calendars (Mike and Steve have been extremely busy on our recap solutions as disclosed a few times this quarter), the auditors, Deloitte, and our own financial close calendar given the other transactions that have diverted attention ($61M direct placement offering). As our standard practice, we will announce our earnings call at least a week prior to. Q: Who is the new 10M share owner? That's more than 5%. Don't they need to file Sch 13 D within 10 days of 10/13/17? Maxim mentioned it was a fundamental health care group. A: Please refer to our 8-K filing related to the direct placement offering settled on Friday, 10/13/17. The investors were not disclosed and should there be a Sch 13 requirement, it is incumbent on the investor to comply. Q: What are the new payors that will cover Afrezza as tier 2, no PA, no STEP, for 2018? A: We continue to make progress on the payer access front and anticipate improvements given the recent FDA approved label change. I anticipate Mike will update on payer access. I’m not aware that the label change moved Afrezza to tier 2, but let me follow up with our Market Access executive. Q: When does Mnkd publish STAT result? By which media channel? A: STAT is an independent, investigator-led study. Accordingly, MNKD does not manage the study. We believe final patient visits and information will be collected over the coming weeks and then analyzed. We anticipate that Dr. Garg will share top-line results with us as soon as available with an expectation that study results will be presented in 2018. I trust you understand that we are not able to give guidance on expectations or study outcomes at this time. c. Q: Does Mnkd plan to partner for inhaled Tresprostinil or go alone? A: As Mike has disclosed, we anticipate filing a pre-IND for Trespostinil and have not focused on partnering this initial step as we currently have the resources to do so internally, hopefully attracting the appropriate partner to take it to the next step, if needed. Q: When will Mnkd finish training the sale force on the new label? A: We quickly mobilized sales training and collateral upon receiving FDA’s approval of the label change. The entire sales force was pulled from the field, east coast in the latter part of the week after receiving approval and the west coast contingency in the early part of the following week. This week represents the first full week the entire sales force is in their respective territories. Good Stuff where was this published?
Q: Mike promised to share more info on the RLS partnership. So far there was none. What's going on there?
A: For the same reasons you have inquired about the RLS collaboration, please know that it has been internally discussed as well. We continue to make progress with RLS and the original scope of our work to trigger the milestone payments
Would love if it was a big name like Paul Allen who is heavy into health care research with the Allen institute in Seattle.
Q: Who is the new 10M share owner? That's more than 5%. Don't they need to file Sch 13 D within 10 days of 10/13/17? Maxim mentioned it was a fundamental health care group.
A: Please refer to our 8-K filing related to the direct placement offering settled on Friday, 10/13/17. The investors were not disclosed and should there be a Sch 13 requirement, it is incumbent on the investor to comply.
So this could be as soon as 10/23 or 10/27 depending on calendar days or business days if there was a 5% investor. Which I hope there was with a big and credible name.
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Post by bill on Oct 18, 2017 9:05:39 GMT -5
lakers Where did your Q&A material come from? Apologies if I missed the reference.
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Post by lakers on Oct 18, 2017 9:29:57 GMT -5
All these are public, previously known info, presented in a cogent format (FAQ) per IR.
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Post by therealisaching on Oct 18, 2017 9:32:21 GMT -5
All these are public, previously known info, presented in a cogent format (FAQ) per IR. Are you saying MNKD's IR replied to you in this format?
Or is some of this your subjective take?
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Post by kbrion77 on Oct 18, 2017 9:36:07 GMT -5
All these are public, previously known info, presented in a cogent format (FAQ) per IR. Please post the link where the Q&A you posted above is from. |
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Post by reality on Oct 18, 2017 9:45:59 GMT -5
All these are public, previously known info, presented in a cogent format (FAQ) per IR. Please post the link where the Q&A you posted above is from. Looks like they are consistent except I DO NOT believe there is going to be a 5% filing. My understanding it's not one entity so the threshold will not be reached. |
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Post by straightly on Oct 18, 2017 9:48:20 GMT -5
Please post the link where the Q&A you posted above is from. Looks like they are consistent except I DO NOT believe there is going to be a 5% filing. My understanding it's not one entity so the threshold will not be reached. I actually hoping these will be small guys who are small enough so they can still strick when they see fit. The big ones will be insiders and cannot trade anymore. |
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Post by liane on Oct 18, 2017 10:00:04 GMT -5
"Mike C eluded to international expansion many times"
Someone needs a vocabulary lesson.
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Post by madog365 on Oct 18, 2017 10:11:33 GMT -5
"Mike C eluded to international expansion many times" Someone needs a vocabulary lesson. Well IR successfully eluded directly answering any of his questions. |
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Post by mnholdem on Oct 18, 2017 11:51:43 GMT -5
"...with the recent approved label update, our partner, BIOMM, wanted to reflect the FDA's approval in its filing with ANVISA."
That's good information, not speculation, and information from the new label will be critical to other international agency reviews.
Thank you!
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Post by lakers on Oct 18, 2017 16:49:05 GMT -5
www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022472Orig1s011ltr.pdfFood and Drug Administration Silver Spring MD 20993 NDA 022472/S-011
SUPPLEMENT APPROVALMannKind Corporation Attention: Robyn Walsh, M.S. Senior Manager, Regulatory Affairs One Casper Street Danbury, CT 06810 Dear Ms. Walsh: Please refer to your Supplemental New Drug Application (sNDA) dated September 22, 2016, received November 30, 2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval supplemental new drug application proposes to amend the Afrezzaprescribing information (PI) with information supported by the results of study PDY14324entitled, “A randomized, controlled, 6-treatment, 6-sequence, 6-period, cross-over dose responsestudy of 3 single doses of Afrezza inhaled Technosphere Insulin and of 3 single doses of SCInsulin Lispro in patients with diabetes mellitus Type 1 using the euglycemic clamp technique,”[Locations Germany Investigational Site Number 276001 Neuss, Germany, 41460 Sponsors and Collaborators Mannkind Corporation Investigators Study Director: Clinical Sciences & Operations Sanofi clinicaltrials.gov/ct2/show/NCT02470637?term=mannkind&sfpd_s=01%2F01%2F2015&rank=3Last Update Posted: April 13, 2017] and study PDY14329 entitled, “An open-label, 2 replicate single dose euglycemic glucose-clamptrial to characterize PK and PD within-subject variability of a single dose of Afrezza inhaledTechnosphere Insulin in patients with diabetes mellitus type 1 (T1DM).” In addition, it alsoproposes to update the PI to comply with the Pregnancy and Lactation Labeling Rule (PLLR).
[Locations Germany Investigational Site Number 276001 Mainz, Germany, 55116 Sponsors and Collaborators Mannkind Corporation Investigators Study Director: Clinical Sciences & Operations Sanofi clinicaltrials.gov/ct2/show/NCT02485327?term=mannkind&sfpd_s=01%2F01%2F2015&rank=2Last Update Posted: March 15, 2017] ......................................................................... PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
comments, (2) the proposed materials in draft or mock-up form with annotated references, and
(3) the package insert(s) to:OPDP Regulatory Project Manager Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road Beltsville, MD 20705-1266 Alternatively, you may submit a request for advisory comments electronically in eCTD format. For more information about submitting promotional materials in eCTD format, see the draft Guidance for Industry (available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf ). You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf. Information and Instructions for completing the form can be found at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm. If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at (240) 402-6149. Sincerely, {See appended electronic signature page} Jean-Marc Guettier, M.D. Director Division of Metabolism and Endocrinology Products Office of Drug Evaluation II Center for Drug Evaluation and Research ENCLOSURES: Content of Labeling Carton and Container Labeling (previously approved on February 17, 2016) REMS (previously approved on April 20, 2015) JEAN-MARC P GUETTIER 09/29/2017
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Post by kite on Oct 18, 2017 16:54:05 GMT -5
www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022472Orig1s011ltr.pdfFood and Drug Administration Silver Spring MD 20993 NDA 022472/S-011 SUPPLEMENT APPROVAL MannKind Corporation Attention: Robyn Walsh, M.S. Senior Manager, Regulatory Affairs One Casper Street Danbury, CT 06810 Dear Ms. Walsh: Please refer to your Supplemental New Drug Application (sNDA) dated September 22, 2016, received November 30, 2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval supplemental new drug application proposes to amend the Afrezza
prescribing information (PI) with information supported by the results of study PDY14324
entitled, “A randomized, controlled, 6-treatment, 6-sequence, 6-period, cross-over dose response
study of 3 single doses of Afrezza inhaled Technosphere Insulin and of 3 single doses of SC
Insulin Lispro in patients with diabetes mellitus Type 1 using the euglycemic clamp technique,”
and study PDY14329 entitled, “An open-label, 2 replicate single dose euglycemic glucose-clamp
trial to characterize PK and PD within-subject variability of a single dose of Afrezza inhaled
Technosphere Insulin in patients with diabetes mellitus type 1 (T1DM).” In addition, it also
proposes to update the PI to comply with the Pregnancy and Lactation Labeling Rule (PLLR).......................................................................... PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
comments, (2) the proposed materials in draft or mock-up form with annotated references, and
(3) the package insert(s) to:OPDP Regulatory Project Manager Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road Beltsville, MD 20705-1266 Alternatively, you may submit a request for advisory comments electronically in eCTD format. For more information about submitting promotional materials in eCTD format, see the draft Guidance for Industry (available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf ). You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf. Information and Instructions for completing the form can be found at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm. If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at (240) 402-6149. Sincerely, {See appended electronic signature page} Jean-Marc Guettier, M.D. Director Division of Metabolism and Endocrinology Products Office of Drug Evaluation II Center for Drug Evaluation and Research ENCLOSURES: Content of Labeling Carton and Container Labeling (previously approved on February 17, 2016) REMS (previously approved on April 20, 2015) JEAN-MARC P GUETTIER 09/29/2017 What is this? |
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Post by agedhippie on Oct 18, 2017 17:40:22 GMT -5
It's a cut and past of the link at the top of the post which is the response letter from the FDA. |
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Post by lakers on Oct 19, 2017 0:32:27 GMT -5
Oct 2017 Sch 13F Creative Planning filed 10/17/17, Bank of Montreal filed 10/16/17, increased Mnkd holding significantly by 933%, 26,785.71%, respectively. whalewisdom.com/stock/mnkdChange "Quarter to View" field to Q3 2017 13F Filings Alternatively, www.nasdaq.com/symbol/mnkd/institutional-holdingsClick on "Date" to list filing in chronological order. Owner Name Date Shared Held Change (Shares) Change (%) Value (in 1,000s) AMERICAN FINANCIAL NETWORK ADVISORY SERVICES LLC 09/30/2017 8,000 8,000 New 38 ATWOOD & PALMER INC 09/30/2017 800 0 0.00 4 BANK OF MONTREAL /CAN/ 09/30/2017 150,560 150,000 26,785.71 715 CREATIVE PLANNING 09/30/2017 211,823 191,318 933.03 1,006 |
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Post by lakers on Oct 20, 2017 11:50:06 GMT -5
International expansion is another opportunity. So we announced BIOMM in Brazil. That deal is moving forward. We have several other markets that are of interest to us that we’ll continue to work on. Those markets are important because of the volume. When you see the plant that we build, it was built to do over $2 billion in sales and $6 billion in cartridges a year. So that’s a fixed cost. Most companies of our size don’t always have that big of a plant ready to go, but this company was meant to be a multi-billion dollar company. And the part of it was meant to take off a little bit faster. But obviously, that didn’t happen so we’ve been readjusting our cost structure. But the international expansion will consume a lot of the volume of insulin in terms of just getting rid of some of the purchase commitments we have with [Indiscernible]. And as you think about the U.S., we’ll get a decent amount of volume here as well. But if you look at cost of pharmaceutical industry, whether we like it or not, the U.S. market is where most companies make their profit and get their growth. And so that’s our major focus and we’ll be opportunistic around some of the other international markets in terms of do we want them for MannKind or do we partner those out, and that’s something that we continue to work through. seekingalpha.com/article/4105856-mannkinds-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-19th-annual-global-investment |
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