The problem I have with the way this unfolded and one of the reasons I have sold out is that there were other options rather than withdrawing the application. Other companies have received a negative opinion as a result of an oral examination and have then been granted a re-examination. At least one of these satisfied all outstanding issues and was subsequently granted a positive opinion. The time frame for this to happen was about 5 months. The withdrawal of the application then must have been influenced by the proposition that the issue was not something that could be resolved within that sort of timeframe. The additional data IMO is likely to require additional trials. My suspicion is that they are not satisfied with the original trial size and that it sufficiently establishes safety of the product. This is a suspicion only and only time will tell.
Rev
TIS Price at posting:
13.0¢ Sentiment: Sell Disclosure: Not Held
