Results of a phase 1 requires a trading halt?
I prefer they have a trading halt. Last time they released some preliminary results during a trading halt but gave sophs an advanced look at them - that was unethical improper and against the terms of the corporate governance statement where they undertake to inform all the shareholders equally. Its like giving the exam questions to some but not others ahead of the market open.
This study only has 30 patients. That is not a particular large n number. They didn't refer to statistical significance previously - just compared mean values 87 something (treatment) versus 51 something for control.
What is a bit of a concern is that they changed the trial protocol part way through to do with daily bandage changing.
With small numbers and standard of care (where standard of care can vary - people do things slightly differently - whilst still 'caring') - any changes part way through a protocol can introduce another change making it harder to have as good a direct comparison between two group.
CYP have gone ahead an acquired the IP from Tekcyte where they didn't have to - that IP was only Australian IP - the patents hadn't been taken anywhere else.
Kilian has taken some risks on this. Protocol changes and advanced exercising of the option - they will not look particularly good if the result isn't good.
I think CYP needs this to be good. Particularly if MSB gets the CRL I expect it to (due to MSB confounding of the potency assay and so not having an adequate study).
Results of a phase 1 requires a trading halt?I prefer they have...
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