MannKind Corp. (MNKD)

[parkourstar]

"What I think one should at least WONDER about is the status of treprostinil-technosphere.

The successful phase 1 trial was announced June 1:

http://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-

successfully-completes-phase-1-trial-treprostinil

...which reassured naive investors:

"The regulatory and development pathway is expected to be capital efficient, using existing safety data of the component API to reduce Phase 3 requirements to a pivotal safety and efficacy trial and a pivotal bioequivalency trial. The regulatory submission in the United States is expected to utilize the 505(b)(2) pathway."

...implying further development would be a cinch for MNKD -- just like they said epinephrine-technosphere was going to be a "breeze" to get past the FDA.

Nevertheless, MNKD turns around on September 4th and basically GIVES tre-t away to UTHR:

https://www.genengnews.com/news/united-therapeutics-to-co-develop-mannkinds-dry-powder-treprostinil-for-pah/

...giving UTHR complete control:

"Under their worldwide exclusive licensing and collaboration agreement, United Therapeutics agreed to oversee global development, regulatory, and commercial activities involving treprostinil—while MannKind agreed to manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Danbury, CT."

FTC clearance came October 15:

https://www.nasdaq.com/press-release/united-therapeutics-and-mannkind-announce-closing-of-license-and-collaboration-agreement-20181016-00203

"As previously announced, the effectiveness of the agreement was conditioned upon expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The requisite waiting period expired on October 15, 2018, and the agreement became effective the same day."

But THEN not ONE word about further development plans was said at EITHER the Mannkind OR the United Therapeutics conferences.

To ME, that seems a bit STRANGE given all the brouhaha about the initial deal. One would think they would have ALREADY had discussions with the FDA and would have been ready to hit the ground RUNNING with a clinical trial once FTC approval arrived. "