Trepostinil is becoming clear to me....

[robbmo]

I was questioning the seemingly sudden shift towards trepostinil from epinephrine, then I ran across this article in my research, and it all became clear...

www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/08/united-therapeutics-sues-fda-after-agency-denies-orphan-drug-exclusivity-for-orenitram.html

[#NoMoreNeedles]

What is clear here? Do you think United Therapeutics is sponsoring the trials?

[itellthefuture777]

Sept 27, 2017 9:56:48 GMT -5 robbmo said:

I was questioning the seemingly sudden shift towards trepostinil from epinephrine, then I ran across this article in my research, and it all became clear...

www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/08/united-therapeutics-sues-fda-after-agency-denies-orphan-drug-exclusivity-for-orenitram.html

FDA claimed that in order to receive orphan drug exclusivity for the oral formulation of treprostinil for use in the treatment of PAH, UTC ‘must demonstrate that oral treprostinil is clinically superior to the other treprostinil formulations by means of greater efficacy, greater safety or a major contribution to patient care (MCTPC).’”...makes sense..All Mannkind has to do is show superiority..nice find!

[robbmo]

Sept 27, 2017 10:10:51 GMT -5 #NoMoreNeedles said:

What is clear here? Do you think United Therapeutics is sponsoring the trials?

What ITell just said.

[anderson]

Could be UT was trying to get another Priority Voucher. United Therapeutics sold the last one they got for 350 million. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm

Voucher info
www.fda.gov/forindustry/developingproductsforrarediseasesconditions/ucm2005525.htm

Hope MNKD gets a voucher

[dreamboatcruise]

Sept 27, 2017 19:36:13 GMT -5 anderson said:

Could be UT was trying to get another Priority Voucher. United Therapeutics sold the last one they got for 350 million. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm

Voucher info
www.fda.gov/forindustry/developingproductsforrarediseasesconditions/ucm2005525.htm

Hope MNKD gets a voucher

I remember being shocked when I heard about how much these vouchers go for.

Have you looked into this?  Could MNKD really get one for PAH if the FDA considered their formulation a meaningful advancement over the existing method of delivery?  Wow, if only that is what Mike meant when he said the meeting with FDA on trepostinil went better than expected... that there is some premium grade hopium.

[mnkdfann]

Sept 27, 2017 19:55:44 GMT -5 dreamboatcruise said:

Sept 27, 2017 19:36:13 GMT -5 anderson said:

Could be UT was trying to get another Priority Voucher. United Therapeutics sold the last one they got for 350 million. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm

Voucher info
www.fda.gov/forindustry/developingproductsforrarediseasesconditions/ucm2005525.htm

Hope MNKD gets a voucher

I remember being shocked when I heard about how much these vouchers go for.

Abbie overpaid bigly.

www.locustwalk.com/what-happened-to-the-value-of-priority-review-vouchers-prv/

Also, the market also now appears to be relatively flooded with PRVs (according to the article analysis above). So high prices like that are unlikely to occur again any time soon.

[letitride]

A PRV could certainly help entice a BP partner.

[lakers]

If Sarepta does manage to sell its PRV for $300m that would give it a strong cash balance of about $420m; nevertheless it has decided to file for a $225m secondary equity offering – a logical use of this week’s share price surge.

www.google.com/amp/s/seekingalpha.com/amp/article/4008098-priority-review-vouchers-revisited

Sarepta Sells Priority Review Voucher for $125M to Gilead
www.raps.org/Regulatory-Focus/News/2017/02/21/26898/Sarepta-Sells-Priority-Review-Voucher-for-125M-to-Gilead/

Smart! Sarepta raised $350 M total. Mnkd could learn this lesson.

[dreamboatcruise]

Sept 27, 2017 23:21:08 GMT -5 lakers said:

If Sarepta does manage to sell its PRV for $300m that would give it a strong cash balance of about $420m; nevertheless it has decided to file for a $225m secondary equity offering – a logical use of this week’s share price surge.

www.google.com/amp/s/seekingalpha.com/amp/article/4008098-priority-review-vouchers-revisited

Sarepta Sells Priority Review Voucher for $125M to Gilead
www.raps.org/Regulatory-Focus/News/2017/02/21/26898/Sarepta-Sells-Priority-Review-Voucher-for-125M-to-Gilead/

Smart! Sarepta raised $350 M total. Mnkd could learn this lesson.

If only we were all young and with pretty balance sheets.

[bioexec25]

Hausenphefer learned this lesson after our pps was already rabbit stew. 🤓