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Wednesday, 05/06/2020 1:55:48 AM

Wednesday, May 06, 2020 1:55:48 AM

Post# of 2795
Hi All,
I found the following text in Mallinckrodt 2020 Q1 earning report transcript (a link to the full copy of the text can be found at the end of this post):

First, we focused on keeping our employee safe, while ensuring the patients we serve have continued access to medicines and therapies. I’m pleased to share that to date we’ve continued to manufacture, supply and deliver our products largely without interruption. Further, while we’re seeing some delays in our clinical studies (due to COVID-19), we continue to make progress on important programs like MNK-6105, as well as franchise modernization initiatives such as Acthar Gel self-injector and INOmax EVOLVE.


And the following:

Notably, we’ve continued to prepare for the initiation of our global Phase 3 trial of MNK-6105, L-ornithine phenylacetate, for the treatment of patients with advanced liver disease suffering from hepatic encephalopathy. You'll recall due to the complexity of this condition and the challenges of conducting a single large pivotal registration trial, we saw the alignment with the FDA through utilization of special protocol assessment procedure, and are working closely with them to finalize study requirements. We continue to anticipate the start of this important trial later this year.



Please note that MNK-6105 is the IV version while MNK-6106 is the Oral version of OCR-002. Mallinckrodt initially planned to start this phase-3 clinical trial by the end of 2019, but postponed to April/2020, then due to COVID-19, it's now moved to later this year.

The prospect of filing bankuptcy is now zero(0) % as the company is going to spin off into independent/publicly traded companies; one with focus on generic drugs with the name retained as "Mallinckrodt", while the other for brand products with the new name as "Sonorant" and trading symbol as SRTX. Hopefully we'll know in details on when the spin-off to start in the upcoming annual general shareholders meeting which is scheduled on 05/13/2020 (next Wednesday)

Link to Q1 2020 earning report transcript:
https://seekingalpha.com/article/4343174-mallinckrodt-plc-mnk-ceo-mark-trudeau-on-q1-2020-results-earnings-call-transcript?part=single

Link to MNK-6105 clinical trial page:
https://clinicaltrials.gov/ct2/show/NCT04128462

Links to the announcement for spinning off into 2 companies:
- Original announcement:
https://www.prnewswire.com/news-releases/mallinckrodt-plans-spin-off-of-specialty-generics-business-to-shareholders-300761097.html
- Updated announcement:
https://www.prnewswire.com/news-releases/mallinckrodt-updates-plans-for-company-separation-and-spin-off-of-specialty-generics-business-to-shareholders-300857099.html


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