See how I go today.
The announcement today was interesting, MSB out and about spreading the word to those that will be making the decision to use it or not. Networking the US market may make a very big difference in the uptake of Ryoncil.
I would also imagine that many of those attending would be well informed as to the other 34 possible indications that Ryoncil could have benefits for. Ryoncil sales growth could be incredible.
We have been looking at Japanese sales as a indication for the US market , this is probably a good starting point however the regulations in regards to post approval access is very different. My understanding is in Japan approval must be obtained for any indication were in the US off label use is allowed .
This would be a significant advantage in sales growth in the US however the real value will be in the data that would be gathered from off label use . We could potentially be gathering data in 30 or more indications very soon after approval . This data would at the very least be used to justify trials to add to the approved label extension, it may also be used as supporting data for a much smaller- faster confirmatory trial or possible even in it self be used for label extension. And the costs all covered by the end users and some left over.
Good luck tomorrow all, will it be a buying opportunity ,
No One knows.
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See how I go today. The announcement today was interesting, MSB...
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