The turn down itself, while unwarranted, is not worded so harshly as to suggest this is all over.
Hyperion™ Holmium Laser System for the correction of hyperopia using Laser Thermal Keratoplasty (LTK)
Panel Recommendation: Not approvable since reasonable assurance has not been given that the device is effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling. (12 ayes, unanimous)
The panel recommended that the sponsor provide:
1. cycloplegic refraction data for all outcome variables, where appropriate, and at all time intervals;
2. a full analysis of data on the updated study cohort to reflect the updated cohort minus the actual "first 46" instead of the "first 50" as the sponsor had provided, if the review of the statistical analysis supports non-poolability;
3. Follow-up of a minimum of 300 eyes out to 24 months, with 90% accountability;
4. analysis of the study population for near point acuity; and,
5. analysis of the study population by gender
Let's talk.
1. Isn't this already available and just wasn't presented at the meeting?
2. Isn't leaving out the first 46 patient a good thing?
3. How many eyes will be at 24 months, when? No mention hear about starting over, which was a worst case scenario posted by a lot of people.
4. Isn't this possible to do from the current data. How do we look?
5. Isn't this possible to do as well from the current data?
Also the problem was with the labeling. Would some change in the labeling plus the above lead to approval.
This is what the panel said, not me, not the naysayers who are blasting the whole procedure.
Labeling concerns and viewing the data from different angles. Removing the 46 and waiting for 300 eyes at 24 months.
Huwito, please comment. Naysayers, tell me what I'm missing? |
