Need Help W/ Memory

[rak5555]

I seem to recall that CRL #1 had a delay because of a missing factory inspection (Oragon?). Can anyone recall how many days prior to pdufa we learned about the delay? If there is going to be a delay, surely the FDA would already know it by now. But I don't necessarily think the FDA feels any obligation to notify management in a timely manner, even though it could have devastating impact on business planning and near term cash flow.

[StevieRay]

Apr 4, 2014 17:40:44 GMT -5 rak5555 said:

I seem to recall that CRL #1 had a delay because of a missing factory inspection (Oragon?). Can anyone recall how many days prior to pdufa we learned about the delay? If there is going to be a delay, surely the FDA would already know it by now. But I don't necessarily think the FDA feels any obligation to notify management in a timely manner, even though it could have devastating impact on business planning and near term cash flow.

The History of MannKind:

mnkd.proboards.com/thread/146/history-mankind

March 15, 2010 – FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1402294&highlight=

[biotec]

Rak, The FDA has no care in the world about impact on business planning or cash flow, And why should they care?Like you said FDA has no obligation at all. The FDA already has the money from MNKD for the pfdua.The business side of things dont make a difference to them.

[thekindaguyiyam]

and I would think there there is inter-department cooperation between agencies at the federal govt. If such information is a tell; my guess is that it just isn't made public until FDA approval.

[biotec]

Stevie, Thanks for the info. And thanks for the flash back! I hope in hell I dont have to read another CRL for MNKD.Wow sorry just seemed like yesterday I was crying reading that CRL!Has it realy been 4 yrs? Ive been in the game since 2008. If I had a time machine LOL.

[StevieRay]

Biotec, It’s the least I can do. I think this time next month we will all be very relieved and will soon be counting the scripts as well as more $!

When all you have is a hammer all your problems look like nails. It’s no wonder the FDA failed to recognize Afrezza’s benefits. We will soon have a new precision tool in the diabetic’s tool belt that will give them more control over their disease.

[harshal1981]

In my opinion, CRL due to plant inspection is very rare. Only when there are severe quality control issues found at plant and at first line suppliers (inhaler molders etc.). In recent memory it happened to MAP pharma's pain medication (Map is now part of Allergan). But they had very serious issues with medical device manufacturing.

I don't think any of the previous CRLs for MNKD had any thing to do with plant inspection. If all is well FDA needs minimum three weeks to complete plant inspection. I do believe we will see a 30 day extension in PDUFA. Let's see. I hope I am wrong.

[rak5555]

"I do believe we will see a 30 day extension in PDUFA. Let's see. I hope I am wrong. "

That is exactly my concern. If "delay" is not an option, I would estimate chances of approval as follows:

Both Type 1 and 2 - 70%
Type 2 only - 20%
CRL - 10%

But, if you throw in delay as an option:

Delay - 50%
Both type 1 and 2 - 30%
Type 2 only - 10%
CRL - 10%

[babaoriley]

rak, I would not be surprised to see a short delay, perhaps two weeks. Are you of the opinion that the fact that there is a delay material impacts the chances of approval? I can see some discussions as to labeling and post-approval monitoring extending the process some from April 15 (after all, the staff is busy making life miserable for other candidates!), although I'm not clear that the latter would necessarily require a delay in their decision, as they could agree on the post approval monitoring studies in the weeks after approval.

By the way, your percentages, with which I essentially agree, are not quite as "slam-dunk" as many feel. To me, slam dunk is at least a 95% chance.  But I like our current position very much!

[rak5555]

"Are you of the opinion that the fact that there is a delay material impacts the chances of approval?"

If the delay is purely on the FDA side and they are not asking MNKD for any additional information I do not think it has a material bearing on approval. A short delay of a couple weeks would just extend my 8 year wait another few weeks, but a longer delay starts to eat into MNKD's financial reserves and could trigger the ATM.

My other reason for handicapping a delay is related to my personal trading position. I sold close to 40% of my (enormous) position leading into the adcom on the basis that it was just too great a risk for a retiree. The adcom vote greatly reduces the pdufa risk and as such I am slowly rebuilding my position at what are surprisingly low prices. I am shocked (and thankful) that some of the options are trading at a lower price than 2 weeks prior to adcom.

[babaoriley]

Well, rak, I believe you will be able to rebuild your position a lot easier and more inexpensively now. This delay is just what the doc ordered for the shorts. Shorts seem to always find a way (out). I don't mean to imply that the shorts caused the delay, even I can't be that Machiavellian, but wow.

[ashiwi]

Maybe the delay is to set up post approval trials

[rak5555]

"Maybe the delay is to set up post approval trials"

ashiwi - I strongly agree w/ your speculation. They are likely negotiating trials and post launch safety tracking. The FDA won't accept a verbal agreement for these events and I don't think they will negotiate them post approval. They want written commitments while they still have MNKD over a barrel.

If you believe this, it is another bullish signal that approval is forthcoming.