Biotech Values

[Summer2762]

Absent the availability of such a lower dose formulation in the market if PA32540 is approved, the FDA indicated that it may limit the indication for PA32540 to use in post coronary artery bypass graft surgery (CABG) with a treatment duration not to exceed one year.

This reads like the FDA also wants the lower dose and uses a stick/threat to get it done. If that's the case, I see no issue with this delay. I would even consider this positive for the potential market size.

However, since the lack of lower dosage causing a time limitation on the higher dose is a logical fallacy, the time limitation may indicate a safety issue. Could there be one? Long term usage of omeprazole seems safe enough to me but I am not sure about what FDA thinks.