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Post by silentbob on Apr 7, 2014 8:51:16 GMT -5
Some discussion: www.eyeonfda.com/eye_on_fda/2010/08/when-does-fda-extend-a-pdufa-date.htmlQuote: "The guidance, which was updated in June 2008, provides a complex formula for figuring out the time of an extension based on when the amendment is submitted, however, in every single example that I could find through a Google Search on the topic, the period of the extension was 3 months from the original 10-month PDUFA date." So, it seems the 3 months doesn't mean much. I also did a google for examples and 3 months seems to be the lower bound...
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Post by notamnkdmillionaire on Apr 7, 2014 8:56:09 GMT -5
The Adcom definitely gave the FDA a lot to think about. Again, hopefully it's just time to fully review the new info for labeling etc. another small speed bump.
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Post by silentbob on Apr 7, 2014 9:25:07 GMT -5
I posted the same to yahoo, but failed to add the following reply to nostradonuts: ------------------------- That was a different kind of delay caused by an FDA failure to inspect the Organon factory on time. It was not an official extension. www.drugs.com/nda/afrezza_100113.htmlAn extension is a way for the FDA to move the PDUFA date when a company submitted more data. Call it an excuse so it won't show up as a missed goal date in their statistics. ------------------------- Can anybody else give it a shot?
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Post by Deleted on Apr 7, 2014 10:26:11 GMT -5
Okay, searched "PDUFA Extension" on Google. Here are the first 10 drugs mentioned.
I decided on 10, I didn't peek forward to see what 11 or 15 or 20 would bring.
All these drugs received a 3-month extension
Revlimid - Approved Trametinib - Approved Qnexa - Approved Xiaflex - Approved Takligucrase alfa - Approved Ulciris - Approved Melblez - CRL Feraheme - Approved Benlysta - Approved Rytary - CRL
So - an 80% approval rate after 3-month delay from my quick, statistically under-powered search.
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Post by jmerr on Apr 7, 2014 11:06:57 GMT -5
While I guess it is feasible that the FDA would delay-- I guess to discuss the label and post market studies, I find it very irritating that the FDA would-- After helping Mannkind design the studies for the last CRl amd Mannkind meeting all of the end points, block this life saving drug. Now instead of being an advocate for the health of diabetes, the FDA is becoming a roadblock-- Why?? Why would they do this? What axe do they have to grind---- This stinks-- I am so skeptical of the FDA-- How can a panel of the world's leading scientist and Doctors on this subject vote overwhelmingly to pass this and The FDA drags there feet. I pray it is about the label and after market studies and not politics and money.
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Post by jpg on Apr 7, 2014 11:25:37 GMT -5
I am not surprised by the delay Again I in no way want to come to the rescue of the FDA but what the panel suggested be done post approval is a lot to figure out and organize. Mannkind (and a future potential partner) will want to make certain everything gets done right post approval. I would rather a smart and intelligent way of tracking oncological issues post approval then be faced in 2 or 3 years with a bunch of non scientific folks saying Afrezza makes your hair glow in the dark or something harder to show if not well tracked and torpedo the company. A big pharma partner (hopefully Novartis) and Mannkind would use every one of those 120 days to make certain everything is thought out and tat the gathered data would strengthen post approval marketing.
The future partner would be in on the discussion with the FDA so there would maybe be decreasing barriers to announcing a partnership?
JPG
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Post by jmerr on Apr 7, 2014 11:29:16 GMT -5
I wrote this to a few of my friends who are in this-- would appreciate comments
HI Everyone--
Well-- I guess we just need to get used to the up and down of this stock. IF you believe-- Don't get swept up in the day to day swings.
Having said that---- I must admit-- It is hard to watch--
OK-- The FDA delayed the PDUFA date until July 15th-- back from April the 15th. Is this a setback-- Yes-- I would have hoped after such a positive adcom, they would have come out and approved it. But-- As many on some of the other boards point out-- After an Adcom like this, the panel members of the Adcom and the FDA still have questions- not so much about approval, but how to approve it. It is the opinion of many that I trust that what is going on now is the FDA is trying to figure out what the label will be after approval and also what after market studies they want. This seems to be the underlying thread of the people I trust. What does this mean-- my guess is another roller coaster of up and down-- and the FDA can come in anytime and give us their decision. They do not have to wait until July. Of course-- Not to be Debby downer here but if for some unforeseeable reason they reject this again-- the stock will plummet-- If approved-- I feel a partner will be announced shortly after thereafter and we get another bounce. There are some here who believe that when approved it will be a partner and some believe it will just be a straight buyout. I am thinking partner because over the next few years, the stock should significantly increase and this has been Al Mann's MO but after so long and so much up and down-- a buy out would not be all that bad.
As for me-- I think all of you know where I stand-- Been in it too long not to ride it out-- But I hate we got this delay--
Best of luck to all of us--
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Post by ezrasfund on Apr 7, 2014 11:40:08 GMT -5
It is about politics and money, but it is also about the big "C" cancer scare. Of course it is impossible to "prove" that something does not cause cancer, but especially a therapy that has only been tested for less than 10 years on a limited number of patients (yes, thousands, but...). Afrezza is at an additional disadvantage because the usual testing regimen for cancer would include giving mega-doses to lab animals to accelerate the effects. This can be done with the technosphere particle alone, but not with TI insulin, because the insulin overdose would kill the lab rats. When you are trying to achieve 100% certainty you can be sure you never will.
It is also about the HbA1c paradigm. HbA1c is a very indirect measure of diabetic control and an imperfect tool. It is useful because it gives a long term picture of blood glucose control, but it's shortcomings have now been well discussed. But the FDA has no other measure to use, and thinks it's better to follow the rules to arrive at the wrong conclusion than to risk breaking the rules to arrive at the right conclusion.
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Post by mannmade on Apr 7, 2014 12:18:30 GMT -5
Have a question regarding delay and subsequent announcement... Let's assume this is really a delay so that the FDA can review labeling and format/design of post approval studies as the consensus (of which I am a member) seem to think. At what point does Mannkind and a possible Partner get involved in a discussion with the FDA for their input. Because at the time they get involved I would think they will know Affrezza is being approved for certain...
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Post by dreggy on Apr 7, 2014 12:36:40 GMT -5
I have to disagree with any talk of a potential partner joining in on the FDA discussions. They wouldn't be involved unless they already signed an agreement with MNKD. This would be info that would have to be released.
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Post by orlon on Apr 7, 2014 12:54:12 GMT -5
Has anyone heard from SIERRA? I'm sure she would have the answers. Meanwhile, I think something if afoot within the FDA...to many doctors have to many connections/associations with other pharmaceutical companies or conflicting interests. A little like Congress...that is why it takes so long for legislation to get done, it has to pass through a lot of committees, each with a tasks, each member with one interest or another. All we can do is wait, but it's becoming harder to hold on.
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Post by jpg on Apr 7, 2014 13:08:56 GMT -5
I have to disagree with any talk of a potential partner joining in on the FDA discussions. They wouldn't be involved unless they already signed an agreement with MNKD. This would be info that would have to be released. I am maybe wrongly looking at this from the perspective of senior managment of a big pharma company: These executives would now consider that the big hurdle has been jumped with so positive an adcom. For many reasons the future partner (and Mannkind) would probably find this is the time to jumps in and be part of the process? Pure speculation obviously and we shall soon know if my speculation is worth the paper it is written on. Electronic paper...
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Post by esstan2001 on Apr 7, 2014 13:47:03 GMT -5
jpg-
IMO, Senior Execs also have to balance taking the potential opportunity of a partnership and all it's wild gains against the risks down the road that there is some confounding event- if they can not solidly quantify that event with high degree of certainty, many will just decide to wait for more clarity, & pay up so as not to loose out on all those executive perks. No one wants to be associated with a costly partnership that went south (not that I believe this to be the case here with Mannkind) Hence, why we are here where we are today.
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Post by jpg on Apr 7, 2014 14:23:58 GMT -5
jpg- IMO, Senior Execs also have to balance taking the potential opportunity of a partnership and all it's wild gains against the risks down the road that there is some confounding event- if they can not solidly quantify that event with high degree of certainty, many will just decide to wait for more clarity, & pay up so as not to loose out on all those executive perks. No one wants to be associated with a costly partnership that went south (not that I believe this to be the case here with Mannkind) Hence, why we are here where we are today. I certainly agree.
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Post by silentbob on Apr 7, 2014 15:22:49 GMT -5
So - an 80% approval rate after 3-month delay from my quick, statistically under-powered search. This helps assure investors that an extension is not a bad sign by itself, but we're still left wondering if the FDA is biased against Afrezza for unjust reasons, or if there's just a few dimwitted bureaucrats in charge of the review. Neither of those options are particularly inspiring...
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