Great conversation Quick summary of the fireside chat today.
On oncology program:
FDA was compelled by the data thus they got before start of the trial the fast track designation.
The institutional investors who participated in the offering were very impressed by their oncology program.
They could get safety results during summer this year and soon after some efficacy result and will be sharing that information with the market.
Ed Nash will be focusing on the oncology program going forward as the data will be released.
Paul sounded very optimistic about the progress of the program which was started ahead of the schedule.
On Phase 3 NASH:
The KOLs didn’t believe there will be a need to have a phase2b as the data they have justifies to start the phase3.
They agencies have approved the switch from administration by syringes to pen injector and the vast majority of patients will be dosed with the pen injector as the trial progresses.
They believe based on the fact that Tesamorelin reduced liver fat by more than 30 percent in 60 percent of patients and the recent study conducted by Dr, Loomba confirmed a reduction of 30 percent of liver fat will also result in regression of fibrosis they feel very confident that the drug will decrease the fibrosis.
It sounded they already had the meeting with FDA and will now present it to the EMA before finalizing it as they might need to make adjustments to satisfy both agencies nevertheless they don’t anticipate any issues with both agencies and start the trial by end of third quarter(September) this year.
Paul mentioned they might not be first to have a drug approved for NASH but they could have the best drug for the condition.
On the financing and partnership:
They have enough money for 2021 and 2022 but they might not want to wait until they almost run out of funds and there are many routes to raise funds one would be a suitable partner such as Pfizer or Lilly.
They can cover the center of excellent in liver therapy but are happy to partner with other pharmas to gain the sale force necessary to commercialize the drug to 3 to 5 percent of US population suffering with NASH if and when it gets approved.
They are for now concentrated to dose patients first before a potential partnership agreement.
On Trogarzo drugs:
They want to educate doctors not to wait too long until the viral loads are too high and it is too late therefore they should start the patients on the drug sooner rather later.
The IV push will be launched soon.
They have a medical group who are actively educating doctors in Europe. They anticipate a rebound in sales as economies are gradually opening up.
On Egrifta:
They need to educate the aging PLWH that lipodystrophy will be messing up their health and aging process.
The F8 will be boosting the sales as it is far more patient friendly.
The two new recruits are highly experienced and will be boosting the sales of both drugs.
On valuation:
They know they did make some mistakes in the past and will not repeat those mistakes.
They want to create market awareness of their operations specially the R&D programs so investors buy their shares and have a plan to do exactly that.