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This could very well give JJM and Pepcid AC a competitive advantage differentiating it from its competitors in the market.
Two First Mover Advantages: If successful, JJM would position Pepcid AC, so it could enjoy two first mover advantages in the OTC market. It will be the first H2 drug to obtain OTC approval from the FDA and the first to obtain approval for the prevention of heartburn, not just symptomatic relief. This dual first mover advantages could very well contribute to the success of Pepcid AC in OTC market.
Cons:
Substantial investment to prove prevention claims: The cost to support prevention claim, including clinical studies to prepare for the submission to FDA may represent a substantial investment from JJM...
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