RE:RE:Who else
Biotech...You should re-read the following points...
CEO Pierre Laurin on Q2 2018 Results - Earnings Call Transcript...
1)Moving to Slide 5. For PBI-4050, this process taking a little longer than anticipated, mainly due to the strong interest from potential partners in reviewing additional information around Alstrom syndrome. And gaining a better understanding of the FDA’s view for the clinical development of PBI-4050 for that indication. In this regard, we recently reported good news that the FDA granted rare pediatric designation for PBI-4050 for the treatment of Alstrom syndrome. So if approved for Alstrom syndrome, PBI-4050 would be eligible to receive a priority review voucher.
2)Following the positive dialogue with the FDA, we have been encouraged to pursue this further and we will provide an update based on the minutes of the FDA meeting as soon as we receive them. We’re also meeting in a few weeks with the European regulatory authorities and we believe that we can define a clinical protocol for pivotal Phase III for both U.S. and the EU market and we will update our shareholders once finalized.
3)But to be clear, whilst we have no timeline for closing a financing of this nature, it does remain a possibility. So these plans, combined with the primary objective of causing a meaningful development transaction, give us the confidence that we can bridge the current financial position and ultimately remove overhang from the balance sheet. We will also have the opportunity to potentially refinance the line of credit into a longer dated instrument. We feel that the execution of these other initiatives first will put us in the position to do so. So that summarizes the review of the financials and financial positon.
4)So seeking the smart partnership as we explained at the beginning of the call that leverage the attractive clinical data on these assets in significant markets. And the cash level, as you just explained Bruce, that are sufficient today. And we’re working with the appropriate sense of urgency to increase our cash resources through multiple sources of cash, including business development deals.
...therefore a long process that will completely transform Prometic's financial situation
The true Bio!