PI-88 acheives Fast Track status for liver cancer but does not perform as well in lung cancer
PI-88 has been awarded Fast Track status by the US FDA. The Fast Track program refers to a formal process for interacting with FDA during drug development. PGL has also announced the results of the Phase 2 lung cancer trial. PI-88 did not significantly improve disease-free survival in patients with advanced lung cancer.
Benefits of Fast Track status further accelerate PI-88 development The benefits of Fast Track include: - scheduled meetings to seek FDA input into development plans, - the option of submitting a New Drug Application in sections rather than all components simultaneously, and - the option of requesting evaluation of studies using alternative endpoints
We believe this will significantly accelerate the approvals process for PI-88. FDA approval timelines normally take 12 months however under the Fast Track program, we expect this may be shortened to less than 6 months. Although approval of the Phase 3 trial design via the Special Protocol Assessment has been delayed, today's Fast Track designation reiterates the close negotiations between the FDA and PGL over the past 12-18 months. It also shows the FDA's desire, based on the Phase 2b data, in getting PI-88 approved as quickly as possible.
Lung cancer results have no impact on the potential of the drug as a treatment for liver cancer We do not view the lung cancer results as a negative for PI-88 as a liver cancer treatment. It is quite common for drugs to work better in one cancer indication over another.
No changes to earnings estimates, Buy valuation re-iterated Given we have never ascribed value to the lung cancer indication, today's clinical trial results do not impact our earnings estimates.
In terms of Fast Track status, we expect to decrease our timelines to market launch when we can monitor patient recruitment rates. PGL is confident the Phase 3 trial will start before year-end with full patient recruitment withing 6-9 months.
We reiterate our Buy rating.
PGL Price at posting:
0.0¢ Sentiment: Buy Disclosure: Held
