RE: Newsflow29 Feb 2024 10:31
FX, here's my attempt at thinking through the points you make, only my opinion but here goes...
1. From what I can see with orphan status you have to be fairly well developed and have enough evidence to support your application. So I'm guessing that the recent additional testing and patent evidence makes them more confident of success in an orphan drug designation.
I'm assuming that since Orphan drug status gives 10 year protection in the market, you have to be pretty categoric about your product and have plenty of evidence to back yourself up.
2. Repurposing... I think its company specific as to how they view it and how much risk they are willing to take. Some companies may be gung-ho about it, whereas others may be cautious depending on their business profile.
Obviously any company working on reprofiling will always say its the best thing, its in their interest to do so. (They're hardly going to say 'Check out our new product, its mediocre at best!')
When I talked about 'ownership' issues, it was more about future ownership, I would guess that a party interested would want to know that there was no chance of someone coming in doing the same thing (or very very similar). Even more so if original patents have lapsed. The Orphan designation is good because it is categoric, so alongside a new patent will provide strong IP backing to the product, so someone will be buying something specific, not just an idea.
3. Agree on the selling, imho its not lanstead as they only had 20m or so left anyway. The problem is the company can't issue a TR1 until the person who has sold has told them.
As I mentioned before, market makers can hold up to 10% without having to declare. So in my opinion the sell was stock held by an MM.
Whether it was on a single parties behalf or not is anyones guess.
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