The reason HALO wants to use PFS as primary P3 endpoint is to shorten the trial time. If HALO did not expect much longer OS time than PFS time, then there is no point to take the risk of using PFS as primary endpoint.
PEGPH20 is needed for any future pancreatic cancer drug in high HA patients, as any drug needs to reach the tumor cell for it to work well. That's the beauty of PEGPH20, it's less likely to be replaced by future drugs coming to the market.
That's true. I had a comment on OMED board that they need to combine their pancreatic cancer drug in clinical trial with PEGPH20, otherwise, their number will not be able to math HALO's, even though the two drugs are not really competing with each other.
Will Intel take the risk to miss the boat again?
Before Avago snaps most chip makers. I just can't understand why Intel is such a slow mover. It needs to broaden its product offerings to get enough revenue to sustain its chip manufacturing investment.
Yes, INO is actually a shell company for Dr. Kim's VGX to become a public company. Not sure why people always mix up the old INO with Dr. Kim's company.
REGN founded in 1988. From 1990 to 2000, three phase 3 trial failed. After 2000, moved on to focus on a new type of drug. Finally first FDA approved drug in 2008, and the journey of SP rising started.
INO founed by Dr. Kim around 2000, First drug (VGX3100) will be approved by 2018 or 2019 (same timeline as REGN). You can guess the story after that.
Guess what's the best drugs for diabetes? Insulin.
After screwed up by FDA for two times, MNKD had no choice but to accepting FDA's suggestion of designing the trial. IT's better to get approval with non-impressive label than to get another denial.
CEO said: "we are evaluating exciting strategic options for the China market." Most likely it refers to license agreement to Hisun. Hisun will be able to roll out the product much earlier before OPTIMA P3 is completed.
It totally makes economical sense for doctors to do spirometer test in house. Everytime my son went to his allergy doctor and performed two simple blowing test, my insurance got charged for $45.
It's now illegal to offer free test equipments to doctors from pharm company. Al said they found a cheap spirometric device that can be billed on patient's insurance.
Remember MNKD only charges product cost on Afrezza shipped to SNY. Assuming 75% gross margin, it will be equivalent to $28m retail revenue. SNY certainly gave out a lot of free samples in the initial launch phase. Hopefully free samples will be converted to prescriptions for majority of patients.
I think samples are counted as Afrezza shipment to SNY too. SNY will then lumped them in marketing expense.