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Post by eddiemoy on May 22, 2015 10:26:02 GMT -5
feel free to use anything i wrote. thanks
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Post by vaijon on May 22, 2015 11:59:07 GMT -5
mnkdmillionaire, reading between the lines I got the feeling Hakan was essentially throwing SNY under the bus for their handling of the spirometry issue. Without using the exact words, his attitude struck me as if he was saying, "Look, the rollout was Sanofi's responsibility, we just produce the damn stuff." Unfortunately, that didn't seem like a sentiment that breeds confidence...in anyone involved. Sigh. His facial expression spoke volumes when addressing this. It was as if he was saying "the spirometry issue was as obvious as the light of day and Sanofi were idiots for missing it". That said, you have to hand it to Al for having a Microlife Spirometer on hand and speaking to purchasing large volumes of them to address the situation. BTW, if any of you want one, go to drugstore.com and for $39.99 its all yours. The only issue now is how to get the spirometer to the doctor - Sanofi cannot give it to them as it would be construed as an inducement to write Rx for Afrezza. Figuring out a solution won't take much time, getting it through Sanofi's legal department will. I enjoyed the tour of the factory and the opportunity to speak with some of the engineers who worked on the dreamboat. Seemed like a competent, enthusiastic group. NRx count needs to start climbing and soon. While the partnership deal with Sanofi can be terminated I believe by either party in the future, I don't think Mannkind can survive that kind of restart and at this point in the game, not sure Al would come up with another couple of hundred million to make the transition to a new partner. Does anyone who attended think the guy from Florida left any type of lasting impression on senior management or the board of directors other than Matt asking about the guys Nike golf shirt embroidered with an Afrezza logo? Time to chime in on this thread. I posted on another thread about the potential violations of selected laws and regulations with the Spirometer issue. To be frank, I just don't see a way of MannKind or Sanofi of getting the devices to a doctor without the items being deemed in violation of the regulatory requirements. Neither company is a medical device company sending out "training" materials and the item is to be used to specifically aid in the prescription of Afrezza. The only mitigation would be the fact that Spirometer is in fact used for a whole host of other conditions unrelated to Afrezza. For instance if the ADA decided to "donate" the Spirometers to doctors treating diabetic patients, that would be allowed as the ADA does not sell drugs. Can you see where I'm going with this? Hint Hint.... unrelated third party who has an vested interest in promoting advances in diabetic care!
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Post by mnkdorbust on May 22, 2015 12:28:18 GMT -5
Agreed it's a grey area. Technically if MNKD provided them would that not work since technically they are not selling Afrezza. They are manufacturing it. I have to believe if Al is actively on the hunt he'll solve it if he can as that's what he does. Either way while there are rules in place there are just as many ways to go around them in a legal way such as the potential ADA avenue. Kind of like the stock manipulation, while not legal, nobody can or will do anything about it.
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Post by tchalaa on May 22, 2015 12:29:24 GMT -5
Time to chime in on this thread. I posted on another thread about the potential violations of selected laws and regulations with the Spirometer issue. T o be frank, I just don't see a way of MannKind or Sanofi of getting the devices to a doctor without the items being deemed in violation of the regulatory requirements. Neither company is a medical device company sending out "training" materials and the item is to be used to specifically aid in the prescription of Afrezza. The only mitigation would be the fact that Spirometer is in fact used for a whole host of other conditions unrelated to Afrezza. For instance if the ADA decided to "donate" the Spirometers to doctors treating diabetic patients, that would be allowed as the ADA does not sell drugs. Can you see where I'm going with this? Hint Hint.... unrelated third party who has an vested interest in promoting advances in diabetic care! You seem to forget that the Lung test is part of the FDA requirements and they are allowed to promote AFREZZA using drug sample packs, so the spirometer can be part of the sample pack since it will enable the patient to discover the advantages of AFREZZA! If you can quote the law paragraph prohibiting this handling as described above, it'll be interesting!
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Post by eddiemoy on May 22, 2015 12:45:22 GMT -5
anyone taking the tour ask if the lines are being run 24x7? i don't remember if the tour guide said it was or not. LOL if so they have a downtime of ~10 hours. if they are running them only 5 days a week, downtime for the lines drop to ~6 hours.
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Post by liane on May 22, 2015 12:55:32 GMT -5
The question did get asked. If I remember it correctly, the actual formulation of TI is done in large batches, and that does not run 24/7. But I think he said the 1 fill line is running 24/7.
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Post by vaijon on May 22, 2015 13:03:55 GMT -5
Time to chime in on this thread. I posted on another thread about the potential violations of selected laws and regulations with the Spirometer issue. T o be frank, I just don't see a way of MannKind or Sanofi of getting the devices to a doctor without the items being deemed in violation of the regulatory requirements. Neither company is a medical device company sending out "training" materials and the item is to be used to specifically aid in the prescription of Afrezza. The only mitigation would be the fact that Spirometer is in fact used for a whole host of other conditions unrelated to Afrezza. For instance if the ADA decided to "donate" the Spirometers to doctors treating diabetic patients, that would be allowed as the ADA does not sell drugs. Can you see where I'm going with this? Hint Hint.... unrelated third party who has an vested interest in promoting advances in diabetic care! You seem to forget that the Lung test is part of the FDA requirements and they are allowed to promote AFREZZA using drug sample packs, so the spirometer can be part of the sample pack since it will enable the patient to discover the advantages of AFREZZA! If you can quote the law paragraph prohibiting this handling as described above, it'll be interesting! I understand the FDA requirements, but unfortunately, that a doctor prescription requirement and one that doesn't fall on our companies. Regarding whether or not the Spirometer can be included in a Drug sample pack, there I'll draw the line. Neither Company is a medical device company trying to promote its Spriometer product (which is allowed for a medical device company in limited instances). To say that you can include the Spirometer with drug samples is a stretch. The test is a medical requirement to test lung function which is often performed by doctors for patients with other conditions like asthma. I know you mean well, but the marketing line "Request some samples and we'll throw in a free Spirometer" won't fly. Here is some information on the Anti-Kickback Statute. The statute is broad and there are safe harbors, but I don't know of one that applies here: What are some examples that may trigger the Anti-Kickback Statute? •Advertising or marketing activities on behalf of health care providers ◦Impressions, page views, or eyeballs, e.g., the number of times that an advertisement is served to a viewer. ◦Click-throughs, e.g., when a viewer of an advertisement clicks through to the vendor. ◦Joint promotion agreements, in which more than one company promotes their projects together. ◦Sponsorships. ◦Slotting fees, e.g., payments for a position on a list of vendors. •Strategic Alliances ◦Between hospitals and physicians or between group practices. •Technology and Content Licensing •Affiliate Programs ◦e.g., referral programs on a revenue sharing basis or a percentage of sales resulting from placement of the advertisement? One method of kickback marketing relies on the sharing of customers between websites that are affiliated as they pass the customer back and forth. •Sale of Product or Services ◦Are free products and services offered to encourage their use? ◦Are there upsells to other products and services, e.g., offering a free baseline or starter service or product, and charging for subsequent or add-on services or products? ◦Are there fees to participate in a network of preferred providers? ◦Are services or products offered for free or at a discount, if other, “full price” products are purchased as a bundle? •Publishing Content ◦Does the publication in question charge companies exorbitant fees for article reprints? If so, it may be publishing content just to sell reprints back to the company covered in the story. ◦Subscription fees? Some media companies ask for “scheduling fees” or “subscription fees” to provide editorial coverage to companies. They might get paid $500 for an article, $5,000 for an audio interview, or even $20,000 for a video segment. ◦Advertising revenue (see above)
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Post by eddiemoy on May 22, 2015 13:04:54 GMT -5
hey, let's assume they are not running at peak efficiency of the one line that they have... so using the lower number 100m cart per year, in Q1, they would have produced 25m cart of which 1.6m was used for samples...
if $7.1m represents the 25m cart, that comes out to $0.28 per cart, or $25.56 a box of 90 cart or a months supply. 25m-1.62m(samples, 54k boxes of 30cart each)/90 cart per month = 259.7k boxes @200 average per box = 52m in whole sale rev, but judging from the number i got from CVS, the average box sold should be more like $250 wholesale, so should be $65M wholesale... They are building lots of inventory. from the factory tour, the shelf life is 2years refrigerated, 10 days at room temperature. they've also tested it to last 30 days at room temperature.
hmm....
so in Q2 they would most likely make the same amount, 25m, another $65M wholesale if all sold...
however in Q3 and Q4 it gets interesting as the numbers should triple... or $195M of wholesale product each month. makes the total for the year... $520M wholesale products... from ~$57M at cost from MNKD?
Will wait for Q2 sales numbers from MNKD to confirm if it is similar sales numbers of 7.1m...
should get interesting in Q3 and Q4!!
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Post by eddiemoy on May 22, 2015 13:07:04 GMT -5
The question did get asked. If I remember it correctly, the actual formulation of TI is done in large batches, and that does not run 24/7. But I think he said the 1 fill line is running 24/7. so that would suggest that they have 10 hours of downtime for maintenance or shift changes... interesting...
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Post by Deleted on May 22, 2015 13:10:15 GMT -5
anyone taking the tour ask if the lines are being run 24x7? i don't remember if the tour guide said it was or not. LOL if so they have a downtime of ~10 hours. if they are running them only 5 days a week, downtime for the lines drop to ~6 hours. Thats not what is meant by downtime Eddie. I've tried to explain this to you. Downtime is for preventative maintenance, not because they are shift changing or something like that. The operation IS 24/7, but every manufacturing process runs with an inherent downtime associated with it. With 400 carts/min the design rate, you can back out what amount of PM downtime Matt has assumed in his calcs. Further, using the previous data that Mann provided you can calculate the downtime HE assumed. There is quite a difference between the two, so its clear that Matt sandbagged his numbers far more than Mann did.
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Post by Deleted on May 22, 2015 13:13:02 GMT -5
The question did get asked. If I remember it correctly, the actual formulation of TI is done in large batches, and that does not run 24/7. But I think he said the 1 fill line is running 24/7. This may have been somewhere else, but did anyone ask on the tour about whether the FDA has given their final approval and MNKD is just working through the final QA/QC to-do? That would seem the most logical, as they seem confident of a June startup.
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Post by eddiemoy on May 22, 2015 13:24:24 GMT -5
anyone taking the tour ask if the lines are being run 24x7? i don't remember if the tour guide said it was or not. LOL if so they have a downtime of ~10 hours. if they are running them only 5 days a week, downtime for the lines drop to ~6 hours. Thats not what is meant by downtime Eddie. I've tried to explain this to you. Downtime is for preventative maintenance, not because they are shift changing or something like that. The operation IS 24/7, but every manufacturing process runs with an inherent downtime associated with it. With 400 carts/min the design rate, you can back out what amount of PM downtime Matt has assumed in his calcs. Further, using the previous data that Mann provided you can calculate the downtime HE assumed. There is quite a difference between the two, so its clear that Matt sandbagged his numbers far more than Mann did. right, maintenance... is it normal to have that much maintenance downtime? 10 hours? also the line 1-3 are same rate 400 cart/min but new lines are faster 4-12. but to hit the 2m patients, line rate for the 4-12 must hit something like 660 ish... tour guide mention they are working to make the lines quicker, didn't say how much.
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Post by eddiemoy on May 22, 2015 13:27:35 GMT -5
The question did get asked. If I remember it correctly, the actual formulation of TI is done in large batches, and that does not run 24/7. But I think he said the 1 fill line is running 24/7. This may have been somewhere else, but did anyone ask on the tour about whether the FDA has given their final approval and MNKD is just working through the final QA/QC to-do? That would seem the most logical, as they seem confident of a June startup. the video they showed at the meeting was of the two new lines, had yellow (12u) cartidges. i don't remember what the tour guide said about qualifying the two lines, i would doubt Matt in what he said in the BOA conf. I seem to remember the tour guide saying they don't need to come back for them to approve. also there is a every two year visit they do to the factory. but they are really just interested in the qc records. so they keep really good qc records...
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Post by liane on May 22, 2015 13:28:06 GMT -5
fugacity,
The FDA does not have to come out and inspect the new lines. MNKD just must perform the QA/QC, document it, and have it available when FDA comes through on a routine check.
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Post by Deleted on May 22, 2015 13:45:33 GMT -5
Thats not what is meant by downtime Eddie. I've tried to explain this to you. Downtime is for preventative maintenance, not because they are shift changing or something like that. The operation IS 24/7, but every manufacturing process runs with an inherent downtime associated with it. With 400 carts/min the design rate, you can back out what amount of PM downtime Matt has assumed in his calcs. Further, using the previous data that Mann provided you can calculate the downtime HE assumed. There is quite a difference between the two, so its clear that Matt sandbagged his numbers far more than Mann did. right, maintenance... is it normal to have that much maintenance downtime? 10 hours? also the line 1-3 are same rate 400 cart/min but new lines are faster 4-12. but to hit the 2m patients, line rate for the 4-12 must hit something like 660 ish... tour guide mention they are working to make the lines quicker, didn't say how much. Its not abnormal for manufacturing equipment to come down for a period of days/weeks to undergo this maintenance. Don't look at it as x hours per day. Look at it as x weeks per year. There may be blocks of time to perform PM, and its more economical to do it all at once. Not saying thats the case here, but thats the reason between the discrepancy in the numbers. Also note that the additional lines will be incrementally faster (10-15%).
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