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Post by mnholdem on Aug 27, 2019 5:55:18 GMT -5
J&J hit with over $500MM damages by judge for its role in opioid epidemic. This would be an opportune time for MsnnKind to issue PR that communicated it’s pre-clinical development of non-addicting pain meds and promote their technology even though it’s in the long-term pipeline bucket.
Based upon medical media coverage during the past few years, however, MannKind doesn’t appear to have developed its network of media contacts. Zero coverage of EpiHale during last year’s epinephrine shortage and Mylan woes is just one example of a lost opportunity to promote the pipeline.
During that time period, the dominant discussion on PB was the management’s “team-building” event in Hawaii.
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Post by mnholdem on Aug 23, 2019 14:38:37 GMT -5
Good info.
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Post by mnholdem on Aug 23, 2019 12:34:04 GMT -5
Games aside, there is also the fact that many fund managers hedge as insurance using a variety of buy/sell tactics (ie straddles). Whether they are bull or bear strategies, they minimize losses in the event that share share goes in the opposite direction. It’s not uncommon for a fund manager who trades in $millions every month.
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Post by mnholdem on Aug 23, 2019 7:25:39 GMT -5
I discussed this issue a few years ago when Sanofi priced Afrezza considerable higher than Al Mann wanted. It was a prelude to the Big 3 simultaneouly raising insulin prices in the US by a substantial amount which has led to congressional inquiries. It was disappointing to some that MannKind did NOT lower the price when they took over commercializing Afrezza.
That having been stated, and regardless of Sanofi's pricing, in my opinion preparing for negotiations of foreign pricing is about the ONLY valid reason for initially keeping Afrezza priced at a premium in the USA during launch in the US and international markets. International drug agencies will use US prices to calculate the target price for a drug distributed in their countries. Years down the road, after adoption in foreign markets, can the US price be lowered.
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Post by mnholdem on Aug 23, 2019 7:16:18 GMT -5
Positive:
Mike - You had the opportunity to talk with Dr. David Kendall and I think you can see he has been hard at work building out the scientific story among diabetes thought leaders, through clinical presentations at scientific conferences, upcoming publications in peer-reviewed journals and dozens of interactions with physicians across the country every month. As you may have seen, the ADA standards of care were updated in December to reflect the unique attributes of Afrezza, which are a direct result the new data we generated and published. David has been a great addition to the team and is continuing to make strides in shifting the thought process among his peers. Three years ago we were met with skepticism. Now we are met with people wanting to know and see more. With each study conducted, scientific presentation made, and publication published, we are getting closer to delivering a true shift in this space.
Analysis: I believe this to be true. Afrezza is such a change from the status quo (aka disruptor) for diabetes that it will require much more effort to educate the medical community than would, say, another injectable insulin. Peer-reviewed publications in major medical journals are critical and are way behind schedule. To date, there have been no publications about Technosphere Insulin in any major medical publication. Even CMO Kendall mentioned this last year during a conference call. What could be problematic however is that over the past few years, some major publishers in the class of AMA, NEJM and Lancet, have been accused of losing their objectivity due to alleged influence by giant pharmaceutical companies. These publishers have protocols for submitting peer-reviewed papers and there is often a review committee that can and will work with the authors to add/remove material. It can be a lengthy process that still ends up being rejected. Kendall's credentials may come into play here...
Neutral/Negative:
Mike - We are focused on continuing to drive steady trends with about 6,000 active patients on the product and growing each quarter. We believe there is a tipping point, but don’t know if it’s 1000 scripts a week or 5000. My guess is somewhere in that range, doctors will finally be seeing first-hand enough patients getting results that Afrezza will potentially become their go-to tool for mealtime control. It is possible that a tipping point will come when pediatric patients are able to access Afrezza, but we need to conduct more research in this area to understand the opportunity for patients below the age of 18.
Analysis: This "possible tipping point" is at least two years from now and, as noted above, if MannKind is not successful in using the period between now and label expansion to educate pediatricians then they may face as much resistance to prescribing to minors and they have with prescribing to adults. Perhaps the CEO simply didn't choose his words well, but I saw an immediate red flag with his remark "we need to conduct more research in this area to understand the opportunity..." in regard to pediatrics. Really? He doesn't understand the opportunity? It comes across as implying "I don't know". The remark about the tipping point is almost an admission the CEO acknowledges that his current plan for significant adoption in prescribing to adults may not be a success. Again, it may have simply been a poor choice of words, but I felt immediate alarm over the comment.
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Post by mnholdem on Aug 22, 2019 4:43:53 GMT -5
Unless there are more nominees than available Board seats.  |
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Post by mnholdem on Aug 22, 2019 4:28:10 GMT -5
There is an inconsistency in dosing instructions between the Afrezza Patient site... www.afrezza.com/pdf/Afrezza-IFU-Mar-2017.pdf...and the Afrezza Healthcare Professional site. www.afrezza.com/hcp/prescribing-afrezzaThe patient site illustrates a 1:1 unit conversion between Afrezza and injected insulin while the Afrezza HCP site recommends a 1.5 unit Afrezza to 1 unit injectable insulin conversion: " Conversion: Based on clinical trials, consider a ~1.5x conversion from injectable insulin units to Afrezza Units, to achieve a comparable glucose effect.14,18 Additional dose adjustments might be needed."MannKind is unable to explain why Afrezza's short duration makes it safer to administer higher and/or follow on doses, other than to say that "additional dose adjustments might be needed". |
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Post by mnholdem on Aug 21, 2019 15:51:00 GMT -5
A few years ago, MannKind contracted an outside company (I cannot recall the name) to run MannKind Cares, which handles patient and physician support. I haven’t heard that the contract was ended.
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Post by mnholdem on Aug 21, 2019 15:38:14 GMT -5
After scuttling that deal did Mannkind have to pay to dump that 21000 pounds as bio waste. Somewhat surprised we had that much product manufactured at that point in time I pointed out earlier that document was a shipping quote only. There was never a shipment and it wouldn’t have happened until a deal was signed and the ME clinical trial started enrollment. Production would not have been ramped up for the same reasons. |
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Post by mnholdem on Aug 21, 2019 15:29:31 GMT -5
As I understand it, MannKind’s dosing instructions must follow the label. A common result, as we’re hearing more and more from Afrezza users, is that patients are underdosing and this getting substandard results. It’s also my understanding that patients hesitate taking “too many” units due to the fear of hypos, which has become ingrained into their thinking by injectable insulins’ long duration.
The label is still problematic for training patients.
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Post by mnholdem on Aug 21, 2019 11:55:02 GMT -5
No. I no longer even remember the name of the freight company.
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Post by mnholdem on Aug 21, 2019 10:51:13 GMT -5
So not that it matters now, just curious: was that large shipment of Afrezza a poster at the time had discovered and posted of a scheduled delivery by a shipping company to the UAE - and which caused a large jump in share price - actually legitimate? Yes Technically it wasn’t a shipment, it was a quote but it was legitimate. I followed the breadcrumbs provided and located the document at the shipping company’s website. |
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Volume Six
Aug 20, 2019 16:31:32 GMT -5
via mobile
Post by mnholdem on Aug 20, 2019 16:31:32 GMT -5
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Post by mnholdem on Aug 20, 2019 7:48:39 GMT -5
Good points. While I am far from being a “sycophant” about VDex, their business plan seems to rely heavily on results. As you point out, without empirical evidence, MannKind’s sales strategy cannot include results that are not supported by the label. This is one reason why I believe the former CEO wanted to collaborate with VDex to gather real-world clinical evidence which the FDA now accepts for label upgrades, provided scientific rigors are met in gathering and presenting the clinical data. It seems by now that much of the required lung safety data could have been gathered by ALL clinics that are prescribing Afrezza. It all comes down to management to devise a viable approach to gathering a data pool. You refer to "required lung safety data." What kind of data is required? |
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Post by mnholdem on Aug 19, 2019 10:09:05 GMT -5
Good points. While I am far from being a “sycophant” about VDex, their business plan seems to rely heavily on results. As you point out, without empirical evidence, MannKind’s sales strategy cannot include results that are not supported by the label.
This is one reason why I believe the former CEO wanted to collaborate with VDex to gather real-world clinical evidence which the FDA now accepts for label upgrades, provided scientific rigors are met in gathering and presenting the clinical data.
It seems by now that much of the required lung safety data could have been gathered by ALL clinics that are prescribing Afrezza. It all comes down to management to devise a viable approach to gathering a data pool.
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