The fact that PGL decided to no longer continue with the Special Protocol Assessment process to concentrate their efforts on the US FDA Fast Track one is good news - it means the FDA has formally accepted the study design as well as 2 key issues concerning PI-88 development: patient sample size and disease-free survival as the primary endpoint.
In BP's view, PGL's decision to commence the Phase III trials before the end of the year without the SPA is impressive as shows the company wants PI-88 approved as fast as possible. Continuing with the SPA would have delayed commencement of the trial.
The US FDA Fast Track program was designed to facilitate the development and expedite the regulatory review of new drugs that demonstrate the potential to treat serious or life-threatening diseases where there is an UNMET medical need. There is currently NO drug approved to stop the recurrence of tumours in liver cancer patients that have had their tumour resected (surgically removed). PI-88 is the most advanced drug in development to treat this condition.
FYI, Nexavar is only approved for patients that have not had their tumour resected and offers treatment to a completely different subset of live cancer patients.
$14.20 valuation is maitained, and BP believe that PGL is in a prime position to sign a lucrative co-development deal that would enable PI-88 access to the Asian markets. In addition, the Phase 2b clinical trial data that we saw in April 2007 proved that PI-88 has a good chance of gaining market success.
PGL Price at posting:
0.0¢ Sentiment: Buy Disclosure: Not Held
