RE:RE:RE:RE:RE:RE:What's Next?My understanding of a phase IIb/III is that the patients in the IIb section count in the requiered number of patients in phase III. So less patients to trat in the phase III part. But you need to complet the phase IIb first, see the results, and if good enough, go ahead with the phase III part. So timewise, it would be much longer and to my knowledge, Thera is the only company proposing a protocol including 18 months of treatment. So at best it would mean 2 years for the phase IIb plus 2 years for the phase III, at least one year for preperation of sBLA and submission and review by EMA and FDA. So a phase IIb/III means at least 5 years before possible approval. Sorry, from a competitive point of view it makes no sense.
Tesamorelin is safe, the only downside of a phase III is that results would not be good enough to meet the endpoints. No harm to the patients. The only risk is a financial one and it would be entierly on the company and its shareholders. So the agencies will have to decide what they want.