Huge Concern #1: The approval of Pennsaid 2% is a major factor for NRI. However, the filing confirmed how Mallinckrodt has been in complete control of the approval process, and bullying in the FDA submission process. After NRI strategized that Phase 3 trials were necessary, Mallinckrodt gave them the siff arm. "The Company (NRI) declinced to provide its requested consent...Nuvo did not provide its consent to the change in the Pennsaid 2% Developmental Plan...The Company (NRI) has continued to operationally support Mallinckrodt ...but has specfically reserved its legal rights...to claim damages, to terminate the US Licensing Agreement for default..." Not a blissful marriage, and as Consultant pointed out, they have absolutely no control. More importantly, "there can be no assurance that the current trials and studies will be sufficient for regulatory authoritiies in any jurisdiction..." It would appear that NRI is not very optimistic.
Huge Concern #2: After Synera failed miserably with a dedicated sales force prior to the NRi acquisition, it was picked up by NRI and was launched again in February. "In September the Company *NRI) terminated its agreement with is contact sales organizatin and refocuses..." With absolutely no successful experience in marketing, NRI tried to this one on their own, one a patch that the market already didn't want.
Huge Concern #3: Completely agree with Consultant. "The company has minimal influence on Pennsaid/Pliaglis". "The company is not responsible..." Oddly, it appears that it has the most control over Synera, the patch nobody wants.
Huge Concern #4: Stated is a lot of uncertainity in the future. And they do not have the resources to deal with any of the potential threats.
Wow, a sobering report. Bonuses to follow!