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Post by mnholdem on Jun 5, 2018 3:18:47 GMT -5
It's the Tyvaso inhaler, which was the original topic of this thread until kastanes brought up Liquidia. I haven't managed to locate a reliable image of the device Liquidia will be using with their Trespostinil drug, though.
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Post by mnholdem on Jun 4, 2018 19:50:30 GMT -5
30% reduction.
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Post by mnholdem on Jun 4, 2018 19:12:39 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device. Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation. So even if it is deemed merely non-inferior I'd guess they could achieve market success. Form factor will be a huge advantage with TrepT. Also I believe the patients might not have to take 4 treatments a day with TrepT. The reason now is because the nebulizer is limited in the amount of drug that can reach the lung. Hopefully TrepT will give them more than enough medicine so they don't have to do it 4x a day. Regarding partnership deals? Well Liquidia got $200M+ for a pump that is attached 16 hours a day. If MNKD can get a clean Phase 3 READOUT they could get 4x that amount. A collaborating partner could step in based on preliminary results. The Antipated Readout of the Phase 1 SAD Study is slated to be completed by the 3rd Quarter of this year and the Phase 3 "PROs, Safety and Tolerability Study" is scheduled to begin with the 1Q19 Start Switch Study and conclude later that same year with The Pivotal PK Trial. At the ASM Kendall announced an anticipated NDA submission for TreT sometime in 2020. I would expect a collaborative partner partner to be announced in mid- to late 2019 if primary targets from the trial are met.
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Post by mnholdem on Jun 4, 2018 14:21:31 GMT -5
If memory serves (I'm on shaky ground at my age) the Pfizer insulin is worth over $1 billion. Al Mann got it for pennies on the dollar.
Also, PB members have recently pointed out that the Amphastar purchase agreement contract has some exclusions for a few global regions/countries.
Taking these two factors into account, I think that MannKind will get the stockpiled insulin qualified in due time.
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Post by mnholdem on Jun 4, 2018 8:53:22 GMT -5
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Post by mnholdem on Jun 1, 2018 14:54:51 GMT -5
Most of the large investment firms won't recommend stocks under $5 to their clients or set ratings and price targets so, obviously, would be a huge advantage for MNKD to get above that $5 threshold.
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Post by mnholdem on Jun 1, 2018 10:53:13 GMT -5
Medical Cannabis Sales are Projected to Rise on a Global Level Published: Jun 01, 2018
Excerpt: NEW YORK, June 1, 2018 /PRNewswire/ -- According to a research report published by Oristep Consulting, the global medical cannabis market in 2016 was valued at USD 12.67 billion and will reach USD 33.41 billion by 2022 at a CAGR of 17.53% during the forecasted period. Scientific studies of the cannabinoid chemical have already resulted in two FDA-approved medications in a pill form. The two main cannabinoids are THC and CBD, which are known to be used for medical purposes as treatments for numerous conditions such as multiple sclerosis, arthritis, epilepsy, glaucoma, HIV, chronic pain, Alzheimer's, cancer and others. The report also indicates that North America leads the market holding nearly half of the market share in 2016. Snipp Interactive Inc. (OTC: SNIPF), PotNetwork Holdings, Inc. (OTC: POTN), InMed Pharmaceuticals Inc. (OTC: IMLFF), Namaste Technologies Inc. (OTC: NXTTF), Kaya Holdings, Inc. (OTC: KAYS).
In a report by Benzinga, Viridian Capital President Scott Greiper points out that the cannabis market received $1.23 billion investments in the first five weeks of 2018, up from $178 million a year earlier.
Source: www.biospace.com/article/releases/medical-cannabis-sales-are-projected-to-rise-on-a-global-level/
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Post by mnholdem on May 31, 2018 10:27:22 GMT -5
Costs to insurers/patients will still play a part in the future, IMO, especially for global treatment options.
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Post by mnholdem on May 29, 2018 20:05:28 GMT -5
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Post by mnholdem on May 24, 2018 12:08:26 GMT -5
Perhaps you're on to something with your comment about CGMs.
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Post by mnholdem on May 24, 2018 11:51:59 GMT -5
Oh-oh! The Caps "hockey stick" graph is showing declining returns...not a good sign for a fan, my friend.
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Post by mnholdem on May 24, 2018 11:45:45 GMT -5
Afrezza's adverse events are on the decline, but take a look at the rise in adverse events over the past few years related to the Humalog QuikPen:
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Post by mnholdem on May 24, 2018 11:37:32 GMT -5
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Post by mnholdem on May 24, 2018 10:43:06 GMT -5
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Post by mnholdem on May 24, 2018 8:01:12 GMT -5
Source: professional.diabetes.org/content-page/living-standards Living Standards
Guidance for Incorporating Updates to the Living Standards
Beginning with the 2018 ADA Standards of Medical Care in Diabetes, the Standards document will be a “living” document where notable updates are incorporated into the Standards, as determined appropriate by the Professional Practice Committee (PPC). Updates will be made in response to important events inclusive of, but not limited to:
- Approval of new treatments (medications or devices) with the potential to impact patient care;
- Publication of new findings that support a change to a recommendation and/or evidence level of a recommendation; or
- Publication of a consensus document endorsed by ADA that necessitates an update of the Standards to align content of the documents.
Recommendations for living Standards updates can be generated from:
- Submitted comments received via the ADA website;
- A recommendation from a member of the PPC; or
- A recommendation from a staff member of ADA.
Once a living Standards update recommendation has been received by the ADA home office and/or the PPC Chair:
1. A proposed language change will be drafted within the relevant section(s) of the most current Standards.
2. A narrative summary and justification (with supporting literature) and the proposed living Standards update will be distributed to the PPC for review.
3. An email vote will be taken from members of the PPC to determine:
- Is the change sufficiently notable to warrant a living Standards update?
- Is/are the proposed edit(s) acceptable as proposed, or are there any suggestions for revision?
- A majority vote (>50% agreement) of the PPC will be required to ratify a proposed living Standards update.
4. If a proposed living Standards update is approved by a PPC majority, the PPC Chair will submit a final summary of the approved change to ADA for processing. 5. Updates will be posted online as annotations in Diabetes Care (full Standards) and, when appropriate, Clinical Diabetes (abridged Standards). 6. ADA will update the Standards slide deck, Standards app, professional education programs, and selected other materials to be consistent with living Standards updates.
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