Hi Itsa, I hope you are recovering well.
My understanding is that the combination study has two components that are already patented for targeted disease, as a hypothetical example, ATL-1102, patented for DMD, and a Sarepta product patented for DMD, both owned already by the 2 collaborators.
So I don't believe there is any further patent required at this point as both are already patented.
Collaboration could take a variety of pathways if it moved forward commercially, whether it be independently but in unison or harmony, or whether there was a manufactured combo product, or something else.
I am not sure but if 2 products were somehow combined that may leave room for a patent, but I would consider two separate already patented products working in harmony would be more likely.
That said, from a speculative view, you never know what NEW information can be discovered when 2 drugs used in unison come together for the first time, something unexpected possibly?
Interpretation of data is very dynamic and could have surprise twists or turns. Analysis can travel across scientists, Regulators, and company Boards before determining what is valid or successful, let alone commercially possible. And all areas do as they do, timeframes can blur somewhat, it's the nature of the game.
I believe we will or would be informed if the outcomes of combo trials are either beneficial or not beneficial.
Timing can be a relevant thing, and it can be complicated.
A combo trial is not a Phase trial, and we have a Phase 2 trial showing safety and evidence of efficacy.
So if the combo trial is successful it has to fit in with being acknowledged potentially prior to final confirmation via a proxy Ph3 via Ph2B trial.
So if you think about managing information outflow and the timelines involved, it is not simply announcing it as we know it.
It would be a package of elements that would need to come together at the appropriate time, ie what would be a sweet spot of an announcement?
But that is looking at it from a positive position until something is announced, it's all speculation.
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