RE:Can someone explain
PWIB123 wrote: Can someone explain what it means now that THTX didn't meet the endpoint for IM? It sounds like it's going back through the process again. Is there a way for it to get to the endpoint? What impact does this have on the patent extension and ability to use this method of administration of the drug of it doesn't ever meet the endpoint? I think this is a surprise to everyone. What would even cause the formula to react this way?
Now it makes sense that Marathon removed that date related to IM. Did the company have a clue and proactively sought to remove that or did Marathon know and remained committed to providing funding anyway?
My understanding is they used the same formulation and about same volume of the drug for the IM as the current IV. Administration of any drug by injecting it into veins is much easier to control the drug's concentration over the period of a time however the drug's bioavailability when administered by IM method is not as predictable as it has to get absorbed into bloodstream. The drug is water based so I guess the they thought the bioavailability won't be an issue. My take is the IM administration didn't achieve the same concentration for the period of time necessary so as a result the reduction of viral load didn't meet the endpoint. Now they will be trying to figure out how to solve the issue. Changing formulation, volume, intervals etc.?? Do they need to start from scratch? Or even can they submit the application with the current results? I guess all these questions and possibly some other questions is the reason for seeking advice from experts!