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Hey Dalts, Im certainly not suggesting everyone bombard the company with every question they have, but this quality response I feel is worthy of sharing;

my question was 'why is givinostat not on the competition page of the presentation?' (Ps I met James at the Melb meeting so it's fitting he's followed through w his offer of getting in touch)


It’s great to hear from you. I hope all is well. I saw your email in the in-tray, and I thought I would take the liberty of responding directly. I’d say that the slide in our company presentation is comprehensive rather than exhaustive. In particular, we have mainly looked at this from a US / FDA lens. There are a few quirky drug candidates around that are in development for specific markets. Givinostat is probably one of those. It is a member of a class of drugs called HDAC inhibitors, which are actually more commonly developed for cancer indications. The class hasn’t been fantastically successful in cancer, and there are in general some appreciable toxicities. Givinostat is under development for Europe by a company called Italfarmaco. They’re a good shop, and I think the drug potentially has a place in the treatment paradigm. The data hasn’t been stellar so far, but this is the kind of disease are where a small benefit can be worth something. I would be really interested to see the full toxicity data in due course – I suspect that may be the limiting factor. Italfarmaco haven’t really articulated a clear approach to the US, at least in public, which is sort of our threshold for serious interest. In short, it’s an interesting drug but, if successful, I suspect it will be a fairly circumscribed product. We decided not to complicate our corporate deck too much with these kinds of candidates, but we do follow it on our more detail internal trackers. If someone makes a concerted effort to bring it to the US market, we will promote it to the slide in the next version of the deck! Look forward to speaking soon.All best wishes, James.

It’s great to hear from you. I hope all is well. I saw your email in the in-tray, and I thought I would take the liberty of responding directly.

I’d say that the slide in our company presentation is comprehensive rather than exhaustive. In particular, we have mainly looked at this from a US / FDA lens. There are a few quirky drug candidates around that are in development for specific markets.

Givinostat is probably one of those. It is a member of a class of drugs called HDAC inhibitors, which are actually more commonly developed for cancer indications. The class hasn’t been fantastically successful in cancer, and there are in general some appreciable toxicities.

Givinostat is under development for Europe by a company called Italfarmaco. They’re a good shop, and I think the drug potentially has a place in the treatment paradigm. The data hasn’t been stellar so far, but tis the kind of disease are where a small benefit can be worth something. I would be really interested to see the full toxicity data in due course – I suspect that may be the limiting factor. Italfarmaco haven’t really articulated a clear approach to the US, at least in public, which is sort of our threshold for serious interest.

In short, it’s an interesting drug but, if successful, I suspect it will be a fairly circumscribed product. We decided e ouporate deck too etail makes a concersoz ted effort to bri the slideion e