RE:Complete IncompetenceGreat post Bepando,
I liked it so much that I took the liberty of sharing (hope you do not mind) with PL and Fred along with my own frustrations, questions and concerns. Fred replied within the hour.
Here is his response:
Hi Aldo,
I understand the frustration and anger regarding the resulting share price decline following the call and we understand that the best way to restore confidence in the company and a decent share price will be through expected milestones delivery.
However, you need to know that in the past couple of weeks, we have had relentless pressure from retail shareholders via phone and e-mail to provide reassurance on progress via an update and judged that a call was the most efficient means to achieve this. Our objective was to address the key strands of the updated plan presented to the AGM and give the clearest indications of progress towards delivery possible – a difficult challenge as we are fully aware that only delivery of said milestones will restore confidence and value
The key indicators of progress we wanted to share on the call were :-
o PBI-4050 Partnering
§ Since the AGM, the process has gathered momentum as a number of additional large players have also declared serious interest whilst negotiations have continued
§ We have a competitive process which we are confident will lead to one or more smart partnering deal(s) for this key asset on a reasonable timescale
§ The data in Alstrom Syndrome has proven particularly compelling and we are excited to have a date confirmed with FDA for August 14th to discuss the further clinical program required for approval
o PBI-4547
§ New data presented at the American Diabetes Association meeting which clearly indicate its potential efficacy for NASH
o Cash and Financing
§ We have not, to this date, drawn down a further tranche from the Thomvest LOC given further burn-reduction + progress on other options including BD, Capital Markets and Debt Refinancng
o Ryplazim Pipeline
§ The TMP trial in Sweden is progressing and 5 patients have been dosed to date – the purpose of this trial is to confirm the dosing regime and formulation for external wound-healing indications including DFU. DFU remains a large and potentially very valuable longer-term opportunity – however, we have dug deeper into the wide of acute indications for Ryplazim and are prioritizing the clinical development of those such as deep vein thrombosis, complications with central venous catheters and stroke which we are now confident can be most quickly become commercial opportunities following the full licensure of Ryplazim for congenital deficiency and the appropriate regulatory approvals for these other acute indications
o Ryplazim BLA
§ We are getting excellent advice from a highly-credible external consulting firm which has recommended that we confirm our proposed program of work at a meeting with the FDA to make sure this will address all their concerns. As Bruce mentioned on the call, we will provide an update on timelines as soon as we have more clarity ourselves.
As for the Winnipeg facility, we already have in place contractual obligations and commitments that we need to respect in terms of utilization of the facility. We may as well use it if we are going to pay for it anyway.
I hope this summary is helpful. The messages are positive because there has been real progress. I recognise this is hard for investors to measure from words alone.
We are all shareholders and also affected by the value of our holdings in PLI. We are trying our very hardest to channel this energy into effective action. We are not however, afraid. At the present price – PLI stock is absurdly undervalued.
I reaffirm to you that we are fully committed to delivering on our promises as soon as possible.
Best regards
Fred