Adcom - April 1st

[liane]

www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1889734&highlight=

[savzak]

I'd appreciate any opinions as to whether the scheduling of an advisory committee review is likely to affect the likelihood af a partnership in the near term.

Thanks.

[biotec]

IDK Savzak, Hard to say. Not sure why they need A review.I myself takes this as not great news. I think we are going to see AF like articles soon, And why April 1st? We should find out more with JP Morgan on the 15th. The stock may take a hit in the short term.

All jmo
Bio

[brentie]

Jan 10, 2014 8:21:39 GMT -5 savzak said:

I'd appreciate any opinions as to whether the scheduling of an advisory committee review is likely to affect the likelihood af a partnership in the near term.

Thanks.

I don't consider it a positive for partnership. It may be just one more question a potential partner wants answered before signing on the dotted line. I hope I'm wrong.

[mnkdnyc]

Does anyone know what the percentages for approval are for drugs going before a committee vs no committee.

[babaoriley]

Surfrigginprise! Not exactly the news we were looking for - Martin S. been sending letters to the FDA again?

We'll be taking a hit, that's for sure.

Also, I'm forgetting with the adcom's, if they meet on April 1, will we get the results on that same date? And again, I do think that a 14 day gap between adcom meeting and PDUFA is, if not standard, at least not unusual.

I guess the FDA took Al at his word about Afrezza being the biggest selling drug of all time, they wanted to make sure MNKD got the full treatment before loosing this baby on the public!

[liane]

If I remember correctly - you will have Adcom results same day. They probably will halt the stock that day.

[liane]

The Adcoms are public, so it's likely someone (potentially AF) will do a live tweet as it progresses.

[slushy]

First, can you fully explain what is an adcom (who comprises it, purpose of adcom, etc...).
Second, how likely is it that we get approval with an adcom? Seems that an adcom would be a big negative unless I'm missing something

[mnkdfan]

Brentie,

I very much respect your opinion and you may very well be right about the partnership waiting out for the ADcomm outcome. However, I have always thought that whatever partnership deal that is agreed upon would all carry the contingency protection of FDA approval. Thus, how much of a partnership set-back would an Adcomm pose being 2-weeks before FDA decision. The potential partner would and should move to lock in a deal before the FDA approval to have some leverage with MNKD ahead of the FDA decision. Just my opinion but who knows.

I would think a bigger set-back would be for the FDA to request more technical test results information and then risk dragging the review process out further.

So much for Matt's response of "if there was anything to be discussed". I guess there will be plenty to discuss now.......

MNKDFAN

[liane]

What is Adcom...

www.fda.gov/AboutFDA/Transparency/Basics/ucm222191.htm

[slushy]

If the adcom is simply an independent advisory board made up of industry experts ,wouldn't the adcom just be an admission from the FDA that they don't have the expertise required to make this decision, and not so much an indictment of the product itself? Seems that this is just a response to their fear that this is inhale-able, so they want to cover their own ass...

[rak5555]

Per the attached study, approval rate for drugs w/ adcom is 31% and 46% for those w/ no adcom.

www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119469.htm

[mnkdfan]

Do any of the long timers remember if Exubera went through an adcom? if so, what was the adcom vote split?

Thank you,

[mannmade]

rak what are this percentages based on? first time submissions? as we all know this is not Afrezza's first time to the dance...