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primaus72

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03/02/25

22:02

Post #: 77688286
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Originally posted by sailnyssa: ↑

The presentation in Sydney tonight was interesting.
One concern I have had about the Ph 3 trials is that they are 52 weeks in duration (excluding safety followup) whereas the Ph 2b was 24 weeks only, with the treatment effect leveling off at around 20 weeks. Fred & (mostly) Megan dealt with this question convincingly imo. The expectation is that the effect will be maintained so long as treatment is continued and there is even a possibility (it was not put higher than that) that the treatment effect might improve post 24 weeks. Megan explained that the FDA now requires a minimum of 9 mths of data rather than 52 weeks for a pivotal trial in wet AMD because it accepts that if the treatment effect endures at 9 mths, it is likely to endure for the duration of the treatment. Might they have done a Ph 2 over 52 weeks? Yes, but it would have been a very large trial (basically a Ph 2/3) & prohibitively expensive. My assessment is she and the company are very comfortable with the Ph 3 trial design in this and all other respects. IMO its is highly likely that the Ph 3 trials with their enriched populations will surpass the results obtained in the Ph2b.
A couple of other points.
The preparations for commercial rollout including recruitment (CCO & CFO & others) & market research (ASRS Surveys) has been exemplary imo. Mike (CCO) has a very deep understanding of the market based on 20 yrs plus working in precisley this field. Fred also made it clear that the company was open to a deal in relation to ex-USA rights, but that the US market was too attractive given its size and highly favourable distribution structure to let go. What this means and signals to big BP imo is that if you want the US market you will have to buy the company. I expect that will happen before any ex-USA rights deal is done. Of course, all of this is subject to positive Ph 3 readouts. There was no discussion during the Q&A of any other scenarios presumably because they are too horrible to contemplate.
DYOR.

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thank you - saves me asking the 52w efficacy question on the wednesday

OPT Price at posting: $1.05 Sentiment: Hold Disclosure: Held
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