FDA Ph 2 and ph 3 divergent results on 22 trialsI am one that hopes that TLT will show a very high efficacy rate in Ph 2. If Ph 2 results are great then we may not need a Ph 3. But for those that have had to go to Ph 3, favorable Ph 2 results do not mean Ph 3 will be favorable.
So while I hope that TLT will be the next treatment of choice that works for NMBIC we still need to see what numbers we get for success in Ph 2. If TLT results in Ph 2 are good but still necessitate a Ph 3, then clearly we could be a treatment that shows itself not to be as good as we are all hoping it will be.
Here is a link to the FDA that shows how 22 trials that did well in Ph 2 were not shown to be as favorable in Ph 3. Just for info as we wait....
https://www.fda.gov/media/102332/download