Unless their current (and smallest) tablet has too large a dose. Then they have to either recover the active from the existing tablets and make new ones (not fun), or (if they are lucky and have planned well) they can go back to clinical manufacturing and make new tablets from existing clinical API that has all the necessary stability data. But a new dose - even if just a different amount of active in the same formulation - will need stability data equivalent to that proposed for the clinical program, plus analytical efforts all round. "Rolling stability data" can be negotiated, but it is still an hoop to jump through.
this is where 113 has a (very nice) practical clinical situation; with a 30 mg tablet, there is no need to go through any of the above if the does needs to be adjusted.
Just to answer another post- no, no new patent is required to make changes in the clinic. If the dose really is different, you might want to file one, but there is no requirement.
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