You are right, the products are pretty close. When I attended the FDA panel hearing in May for SPYN, they had the hearing SPYN's product in the AM and USS's in the PM. I stayed for both.
The panel was a lot more impressed with SPYN's application because SPYN had more that 1,000 more patients in their study compared to USS (which had under 300). Plus, SPYN had longer term follow up. In addition, the panel required additional work on USS's data analysis and had some problem with the experiment design. This might account for why SPYN got their approvable letter about three months before USS (with the hearings being the same date).
After reading your posting, and reading USS's release, I called the FDA and asked if they were planning on holding up SPYN's PMA for USS's (to do together) and they said no, that 2 different groups were working on them. The person at the FDA I spoke with would not speculate on SPYN's approval date but implied not much longer. I then called Keith Eastman, SPYN's CFO, and asked him about anticipaed approval date. He said they are in contact with the FDA almost daily and expect the final approval any day (actually a bit dismayed they did not get it yet, indicating there was no reason for delay to date).
According to my doctor, the medical community is more impressed with SPYN's product. Of course, whoever is first to market will be at a great advantage. |
