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Post by seanismorris on Dec 1, 2015 11:41:11 GMT -5
I consider the Pediatric Study extremely important. With good results I think docs would be much more likely to recommend Afrezza regardless of age. The number of patients I'd assume has been determined by discussion between Sanofi and the FDA. I hope the completion of this study leads to a larger one to show Afrezza superiority.
In other words, the completion of this study could be a turning point for investors. If the results are poor...this could be the point where Sanofi backs out of the partnership. If the results are great, then Sanofi finally gives Afrezza the resources it needs to succeed.
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Post by dreamboatcruise on Dec 1, 2015 11:48:15 GMT -5
I consider the Pediatric Study extremely important. With good results I think docs would be much more likely to recommend Afrezza regardless of age. The number of patients I'd assume has been determined by discussion between Sanofi and the FDA. I hope the completion of this study leads to a larger one to show Afrezza superiority. In other words, the completion of this study could be a turning point for investors. If the results are poor...this could be the point where Sanofi backs out of the partnership. If the results are great, then Sanofi finally gives Afrezza the resources it needs to succeed. Whether it is great or not will depend heavily on what protocols they use and what they measure.
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Post by cfield23 on Dec 1, 2015 16:56:45 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents. ^^and completed much quicker.
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Post by Deleted on Dec 1, 2015 17:13:55 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents. ^^and completed much quicker. Everything is falling into place for Sanofi to apply for EU approval. I Don't see any reason not to.
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Post by hawaiiguy42 on Dec 1, 2015 17:59:32 GMT -5
Thanks for the info Kastanes and your due diligence.
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Post by kbrion77 on Dec 1, 2015 18:04:39 GMT -5
^^and completed much quicker. Everything is falling into place for Sanofi to apply for EU approval. I Don't see any reason not to. I try to stay grounded and probably check blogs and sites way too much for MNKD but I do truly believe at some point in time down the road we will all say, "ahhhhhh this is all making sense now." We have a long way to go but sometimes silence is golden.
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Post by rrtzmd on Dec 1, 2015 18:30:11 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents. FDA approval is practically a rubber stamp for EU approval. I believe Mannkind or Sanofi could have applied the day after the FDA approved afrezza and, in all likelihood, the EMA would have granted approval. I imagine the same thing is restraining Sanofi there as it is here -- reimbursement. Sanofi is stuck either lowering the price or offering up solid evidence of cost effectiveness. Stack on receiving only 65% of the profit, and Sanofi probably isn't highly motivated to press very hard for further approval.
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Post by cjc04 on Dec 1, 2015 18:40:34 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents. ^^and completed much quicker. Help me out with some timelines here.... 1. If SNY were to apply right now for EU approval, what's the minimum amount of time to get approval. I believe it would be a minimum of 6 months. 2. Isn't there a deadline for SNY to begin the 8,000 patient study? I thought I remember hearing be the end of January. You see where I'm going with this.... Can the 8,000 person study happen simultaneously for FDA & EU, as is being suggested here, if those two timelines do not match up?
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Post by obamayoumama on Dec 1, 2015 19:48:53 GMT -5
^^and completed much quicker. Everything is falling into place for Sanofi to apply for EU approval. I Don't see any reason not to. The global rollout is like playing Chess. The U.S. pricing is the current benchmark for the rest of the world for Afrezza. The EU tends to have the lowest prices. Middle East would use the U.S. pricing benchmark unless AFREZZA was EU approved and then many countries would use the EU benchmark. Many countries only need FDA approval and SNY can start marketing. The sequence of country's rollout makes a difference in pricing for the world.
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Post by mindovermatter on Dec 1, 2015 20:09:26 GMT -5
Everything is falling into place for Sanofi to apply for EU approval. I Don't see any reason not to. The global rollout is like playing Chess. The U.S. pricing is the current benchmark for the rest of the world for Afrezza. The EU tends to have the lowest prices. Middle East would use the U.S. pricing benchmark unless AFREZZA was EU approved and then many countries would use the EU benchmark. Many countries only need FDA approval and SNY can start marketing. The sequence of country's rollout makes a difference in pricing for the world. Re: US as a benchmark for pricing. Might want to read this as to why the US is not a benchmark for pricing. The US is the only place where a drug firm can charge what ever it wants. www.wsj.com/articles/why-the-u-s-pays-more-than-other-countries-for-drugs-1448939481?mg=id-wsj
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Post by mnholdem on Dec 1, 2015 21:17:17 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents. FDA approval is practically a rubber stamp for EU approval. I believe Mannkind or Sanofi could have applied the day after the FDA approved afrezza and, in all likelihood, the EMA would have granted approval. I imagine the same thing is restraining Sanofi there as it is here -- reimbursement. Sanofi is stuck either lowering the price or offering up solid evidence of cost effectiveness. Stack on receiving only 65% of the profit, and Sanofi probably isn't highly motivated to press very hard for further approval. You seem to indicate that given two choices, Sanofi would choose neither one, or at least would not be motivated to pick one over the other.
I think that, given the potential $$$ involved, Sanofi would be VERY motivated to gather and provide the data for EMA to label Afrezza as superior. Also, seeing how Sanofi is fond of using "strategic purposes" as a catch-all excuse for maintaining silence regarding the development of many of its drugs, they certainly would not immediately publicize a study to gather evidence to demonstrate superiority until they are ready to present it. Unlike the FDA, the EMA approval process requires that trial data be gathered by the applicant beforehand, to be submitted with the application for Centralized Authorization to Market Afrezza throughout Europe. The EMA evaluates the submitted trial data - including any data that has previously been submitted to the FDA - and reviews it in determining whether to grant authorization for centralized distribution of Afrezza throughout all EU countries.
If the EMA were to determine Afrezza to be superior to RAA insulin, approving and labeling it as such, then Sanofi can later submit the EMA trial data to the FDA for labeling purposes in the US. I have confirmed this practice at the FDA website. After all, the FDA often reviews drugs that are being sold in other countries to determine whether they can be sold in the US
So I think that Sanofi remaining silent should not be misconstrued as proof that Sanofi is not motivated. There could be much going on, behind the scenes, of which we are not aware.
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Post by obamayoumama on Dec 1, 2015 21:51:46 GMT -5
The global rollout is like playing Chess. The U.S. pricing is the current benchmark for the rest of the world for Afrezza. The EU tends to have the lowest prices. Middle East would use the U.S. pricing benchmark unless AFREZZA was EU approved and then many countries would use the EU benchmark. Many countries only need FDA approval and SNY can start marketing. The sequence of country's rollout makes a difference in pricing for the world. Re: US as a benchmark for pricing. Might want to read this as to why the US is not a benchmark for pricing. The US is the only place where a drug firm can charge what ever it wants. www.wsj.com/articles/why-the-u-s-pays-more-than-other-countries-for-drugs-1448939481?mg=id-wsjI spoke to Matt on this very subject. Read what I wrote. If SNY is going to start marketing in Isreal and Saudi Arabia and AFREZZA is ONLY approved by the FDA, then the U.S. is the benchmark pricing. If SNY get AFREZZA approved by the EMA then the EMA pricing would be the benchmark for the Middle East and many other Countries. Is SNY looking for volume or profit margins? There is South America as well that can use the FDA approval. It will be interesting to see which Countries will be first as well as the timing.
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Post by lakers on Dec 1, 2015 22:14:30 GMT -5
I spoke to Matt on this very subject. Read what I wrote. If SNY is going to start marketing in Isreal and Saudi Arabia and AFREZZA is ONLY approved by the FDA, then the U.S. is the benchmark pricing. If SNY get AFREZZA approved by the EMA then the EMA pricing would be the benchmark for the Middle East and many other Countries. Is SNY looking for volume or profit margins? There is South America as well that can use the FDA approval. It will be interesting to see which Countries will be first as well as the timing. That's why Sny wants to consider EU launch in the context of World launch and keeps Afrezza US price high for negotiation leverage. Mnkd is qualifying Sny's insulin to lower COGS. Sny also wants a better label, hence the slow expansion. All signs point to Sny ready for international expansion.
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Post by mssciguy on Dec 1, 2015 22:16:16 GMT -5
I spoke to Matt on this very subject. Read what I wrote. If SNY is going to start marketing in Isreal and Saudi Arabia and AFREZZA is ONLY approved by the FDA, then the U.S. is the benchmark pricing. If SNY get AFREZZA approved by the EMA then the EMA pricing would be the benchmark for the Middle East and many other Countries. Is SNY looking for volume or profit margins? There is South America as well that can use the FDA approval. It will be interesting to see which Countries will be first as well as the timing. Isn't there a big diabetes conference in Saudi Arabia in Jan. featuring presentations about Afrezza? BTW--- quick question... benchmark doesn't mean setpoint, right--- it can be a relative kind of pricing, right? Also, as far as outrageous US drug prices, from what I understand, they are often the result of price increases after approval and coverage (e.g. Shrekeli's price gouging recently)
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Post by obamayoumama on Dec 1, 2015 22:28:24 GMT -5
I spoke to Matt on this very subject. Read what I wrote. If SNY is going to start marketing in Isreal and Saudi Arabia and AFREZZA is ONLY approved by the FDA, then the U.S. is the benchmark pricing. If SNY get AFREZZA approved by the EMA then the EMA pricing would be the benchmark for the Middle East and many other Countries. Is SNY looking for volume or profit margins? There is South America as well that can use the FDA approval. It will be interesting to see which Countries will be first as well as the timing. Isn't there a big diabetes conference in Saudi Arabia in Jan. featuring presentations about Afrezza? BTW--- quick question... benchmark doesn't mean setpoint, right--- it can be a relative kind of pricing, right? Also, as far as outrageous US drug prices, from what I understand, they are often the result of price increases after approval and coverage (e.g. Shrekeli's price gouging recently) Yes, Benchmark is a reference price.
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