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Post by mbracket123 on Apr 9, 2016 10:21:43 GMT -5
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Post by mnholdem on Apr 9, 2016 10:34:37 GMT -5
I still think Sanofi will face difficulty convincing an arbitor that they made "reasonable efforts" at marketing Afrezza. One may argue that they did not have a desirable label to work with. Typically, if that's the case you compete on price. Sanofi's 30%-50% premium over competing RAA insulin is indefensible. Then CEO Alfred Mann, in his Sept 2014 interview with DiabetesMine, expressed his desire for Sanofi to price Afrezza to be competitive with insulin pens, but he also acknowledged that all the authority for determining pricing was given to Sanofi.
IMHO, no pharmaceutical company would tack on a high premium price tag to a drug determined by the FDA to not have superiority UNLESS a superiority study were planned. That is what I & others thought was happening. Sanofi will have a difficult time explaining their actions. Their sales reps mistakenly informed endos that a full pulmonary test was required when only a 2-minute FEV1 was mandated...the list is lengthy of the ways Sanofi screwed up.
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Post by rockstarrick on Apr 9, 2016 11:18:31 GMT -5
Lakers has been on except for SNY ending partnership. Everyone was blind sided by that....even management though they I think they did see the writing on the wall. Not me !! Cough, cough, hack, hack, sanophooey !!!!!
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Post by agedhippie on Apr 9, 2016 12:04:55 GMT -5
I wouldn't contest the price. That is easy to defend against since it's a marketing decision and commercial decision and those fall within Sanofi's rights in the contract. Arbitration will penalized for breaching the contract but not for making the wrong decision if it was your's to make. There is no marketing reason that I can see to price Afrezza the way that they did, but there are commercial reasons (had to increase the the price to account for the split, or because they anticipated a slow launch and needed to control the costs).
If I was Matt I would go for the like-for-like clause where Sanofi agree to handle Afrezza as if it was their own drug. I would want to see what the comparables looked like for their other launches. I think that is the most likely area to be supportable at arbitration. The risk is that Sanofi have had months to dress this up in a way that looks like they did what they should so it will take a lot of time and resources on the Mannkind side to counter that.
Arbitration is a double edged sword. You cannot play to the emotions of the jury but on the other-hand the arbitrators really want to understand the detail.
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Post by mnholdem on Apr 9, 2016 14:12:55 GMT -5
Good post. I think the double-edge sword is an excellent analogy. One question that I ponder is whether a drug's price is integral to marketing it, especially when you must first market your drug to PBMs trying to get good tier placement so that patients get coverage.
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Post by od on Apr 9, 2016 14:30:04 GMT -5
I still think Sanofi will face difficulty convincing an arbitor that they made "reasonable efforts" at marketing Afrezza. One may argue that they did not have a desirable label to work with. Typically, if that's the case you compete on price. Sanofi's 30%-50% premium over competing RAA insulin is indefensible. Then CEO Alfred Mann, in his Sept 2014 interview with DiabetesMine, expressed his desire for Sanofi to price Afrezza to be competitive with insulin pens, but he also acknowledged that all the authority for determining pricing was given to Sanofi. IMHO, no pharmaceutical company would tack on a high premium price tag to a drug determined by the FDA to not have superiority UNLESS a superiority study were planned. That is what I & others thought was happening. Sanofi will have a difficult time explaining their actions. Their sales reps mistakenly informed endos that a full pulmonary test was required when only a 2-minute FEV1 was mandated...the list is lengthy of the ways Sanofi screwed up. "Their sales reps mistakenly informed endos that a full pulmonary test was required...", Source (besides anecdotal postings)? Thanks.
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Post by kball on Apr 9, 2016 14:40:05 GMT -5
I still think Sanofi will face difficulty convincing an arbitor that they made "reasonable efforts" at marketing Afrezza. One may argue that they did not have a desirable label to work with. Typically, if that's the case you compete on price. Sanofi's 30%-50% premium over competing RAA insulin is indefensible. Then CEO Alfred Mann, in his Sept 2014 interview with DiabetesMine, expressed his desire for Sanofi to price Afrezza to be competitive with insulin pens, but he also acknowledged that all the authority for determining pricing was given to Sanofi. IMHO, no pharmaceutical company would tack on a high premium price tag to a drug determined by the FDA to not have superiority UNLESS a superiority study were planned. That is what I & others thought was happening. Sanofi will have a difficult time explaining their actions. Their sales reps mistakenly informed endos that a full pulmonary test was required when only a 2-minute FEV1 was mandated...the list is lengthy of the ways Sanofi screwed up. "Their sales reps mistakenly informed endos that a full pulmonary test was required...", Source (besides anecdotal postings)? Thanks. kball the pessimist opines: Perhaps the reps did this intentionally to curb sales (in addition to 'slow walking' better insurance coverage and 'no walking' label improvement, or launch in any other country) so Sanofi could more easily implement their lowball buyout offer on weak sales data?
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Post by od on Apr 9, 2016 14:50:29 GMT -5
"Their sales reps mistakenly informed endos that a full pulmonary test was required...", Source (besides anecdotal postings)? Thanks. kball the pessimist opines: Perhaps the reps did this intentionally to curb sales (in addition to 'slow walking' better insurance coverage and 'no walking' label improvement, or launch in any other country) so Sanofi could more easily implement their lowball buyout offer on weak sales data? od the realist replies: No doubt, reps intentionally misinforming providers re: FEV 1 would compromise prescribing, but did they?
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Post by mnholdem on Apr 9, 2016 15:43:51 GMT -5
od , I'll find the link for ya, but it'll have to wait until tomorrow. Two of my grandkids are on their way over for the evening. Family first, sources second. Somebody else here may remember the source. It's either on this board or a recent article, possibly one of Rodriguez's recent pieces.
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Post by od on Apr 9, 2016 15:46:34 GMT -5
od , I'll find the link for ya, but it'll have to wait until tomorrow. Two of my grandkids are on their way over for the evening. Family first, sources second. Always!
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Post by od on Apr 9, 2016 17:36:52 GMT -5
od , I'll find the link for ya, but it'll have to wait until tomorrow. Two of my grandkids are on their way over for the evening. Family first, sources second. Always! mn, no need to respond to my query. Your recent comment to Stevil, from a moderator, no less, informs me this is not a community with which I should continue. It has nothing to do with Stevil's 'way', it is about my personal feelings that at this point in my arc (likely closer to you than him), I want to be with and work with the people I want to be with and work with.
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Post by mnholdem on Apr 9, 2016 21:13:20 GMT -5
Everyone is entitled to their opinion. Even a moderator, which you'll find on the rules of the board. I thought that my statement was a fair analysis of a member who uses facts selectively, which was confirmed when, in his farewell post, he finally answered those who've questioned his motives for months by confessing that he has had an agenda for posting on this forum.
I truly think it's a shame that he decided to become a crusader who felt it was his duty to "bring balance" to the board. I gave him the benefit of the doubt. Quite a few others apparently saw his agenda way before I did.
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Post by jerrys on Apr 9, 2016 22:24:06 GMT -5
I still think Sanofi will face difficulty convincing an arbitor that they made "reasonable efforts" at marketing Afrezza. One may argue that they did not have a desirable label to work with. Typically, if that's the case you compete on price. Sanofi's 30%-50% premium over competing RAA insulin is indefensible. Then CEO Alfred Mann, in his Sept 2014 interview with DiabetesMine, expressed his desire for Sanofi to price Afrezza to be competitive with insulin pens, but he also acknowledged that all the authority for determining pricing was given to Sanofi. IMHO, no pharmaceutical company would tack on a high premium price tag to a drug determined by the FDA to not have superiority UNLESS a superiority study were planned. That is what I & others thought was happening. Sanofi will have a difficult time explaining their actions. Their sales reps mistakenly informed endos that a full pulmonary test was required when only a 2-minute FEV1 was mandated...the list is lengthy of the ways Sanofi screwed up. A full pulmonary function test is required to meet the standard set forth on the insert:
"Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients."
The FDA is simply using "FEV1" as an abbreviation for "pulmonary function test." It is not possible to identify "potential lung disease" without the full complement of tests. This video gives a pretty demonstration of what usually happens:
www.youtube.com/watch?v=1rjN2_hDXEY
And this is the first in a series of videos that explains interpretation of the results:
www.youtube.com/watch?v=S9OWa8ot75o
That might help explain why endos are reluctant to provide spirometry.
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Post by qwertqwert on Apr 9, 2016 23:12:14 GMT -5
It also says "Previous experience in diabetes strongly preferred". My guess is osteoarthritis is a typo from a poor cut and paste effort. You are totally right! See the exact same posting by Flexion Therapeutics here (google cached)Looks like @iam2sekc4u2002 beat me to it.
They didn't just cut and paste without reading. Not taking from the above link either. Notice there are no periods after each bullet point, mnkd post has. Also, one double space between "product" and "for".
Looks like they used the "ZILRETTA for osteoarthritis" posting and replaced with "product for osteoarthritis". They knew quite well that osteoarthritis was in there, that's a big word not to notice!
They quickly removed it when Amgen noticed. Dead giveaway linking them to the job.
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Post by kc on Apr 10, 2016 8:11:44 GMT -5
I still think Sanofi will face difficulty convincing an arbitor that they made "reasonable efforts" at marketing Afrezza. One may argue that they did not have a desirable label to work with. Typically, if that's the case you compete on price. Sanofi's 30%-50% premium over competing RAA insulin is indefensible. Then CEO Alfred Mann, in his Sept 2014 interview with DiabetesMine, expressed his desire for Sanofi to price Afrezza to be competitive with insulin pens, but he also acknowledged that all the authority for determining pricing was given to Sanofi. IMHO, no pharmaceutical company would tack on a high premium price tag to a drug determined by the FDA to not have superiority UNLESS a superiority study were planned. That is what I & others thought was happening. Sanofi will have a difficult time explaining their actions. Their sales reps mistakenly informed endos that a full pulmonary test was required when only a 2-minute FEV1 was mandated...the list is lengthy of the ways Sanofi screwed up. "Their sales reps mistakenly informed endos that a full pulmonary test was required...", Source (besides anecdotal postings)? Thanks. A good example is that Sanofi even owns a company that sells Spirometer equipment but did not even connect their own dots to this until last September when Mannkind was working on the solution for the testing. The spirometer company is a division of Sanofi-Pasteur its called Vax Serve. Why did Sanofi not engage this solutIon back in August 2014 when the partnership with Mannkind was created. They knew the FDA rule on testing. They owned a solution but didn't offer it up until the problem really became deadly critical to the marketing of Afrezza. They purposely tried to stall or kill Afrezza. www.vaxserve.com/static/spirometry/products.htmlthis message at the bottom of the Vax serve web page. VaxServe is a Sanofi Pasteur company and a national healthcare supplier dedicated to serving the needs of our customers. So why did Sanofi originally fumble the spirometer issue if not on purpose.
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