RE: Advert16 Jun 2020 06:29
Bothwell,
They keep writing about the US etc, however. They certainly appear to keep dragging their feet and have no clue on timelines. One would think that if they were so confident on the US, they would spend more time in getting dates right.
As mentioned before, on the 11th March PLE announced an "FDA have unambiguously defined a path to a successful submission of the New Drug Application for PSD 502".
This is now over 6 years ago. It surely doesn't take that long to sort out phase II. Every date they have given has been wrong, the latest being the completion of phase II. ts inherent, they couldn't even get the Recordati, HK launch dates or China submission date correct. Its managements incompetence.
They also go on to state that "The Company sees a significant potential market opportunity for PSD 502 both in the United States and EU. Based on the Company's internal modeling and pricing input from its US marketing consultant, the Company forecasts in excess of US$1 billion per annum peak prescription sales. It therefore sees significant value in PSD 502 for the Company's shareholders and correspondingly, management is to looking to unlock that value as quickly as possible through bringing to closure negotiations with potential marketing partners. In this respect, the Company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories. Negotiations are at a more advanced stage with a number of potential marketing partners and the Company is hopeful that an announcement will be made in this regard over the coming months"
Given that that was written all that time ago, where are the US license agreements? Even a Chinese license agreement has been signed, which was not even on the cards until towards the end of 2016 (no big achievement since we still have another 3 to 4 years to wait, but at least the Chinese have committed). Where is the potential in the EU which they were so confident about? They did no market research in the EU and they have done absolutely diddly squat for the US. Instead, they keep paying an incompetence salary of 8% of the current market cap to someone who doesn't deserve it.
In the PLE 11th Nov announcement of the same year (after the unambiguous FDA agreement), they stated "Clarifying and confirming the anticipated timelines relating to the NDA filing and potential approval of FORTACIN™ in the US. The Company expects to complete the filing of the FORTACIN™ NDA incorporating the new can size (6 doses, 3 sprays per dose) by Q4 2015 /Q1 2016. Once the filing has been made the Company anticipates a 10 month Prescription Drug User Fee Act review with commercial launch in the US expected in 2017'.
Now adding the extra year for the change to the 12 dose canister, means we should have launched in 2018. Instead, we wont be launching till 2022', 4 years on and at an extra 6 mill USD in salary. And we wont even be launching with the 12 dose can, but the original 20 dose !!!