Hi RJ,
I'm not sure what you mean by a Global trial as I don't think this even exists. The world is broken into several jurisdictions that try to align, but often don't, hence the requirement for seperate and independant trials for the same drug. But if you mean develop a drug for global adoption, then absolutely yes.
Putting the pieces together at the moment is somewhat difficult without much more information, so it becomes educated forecasting or plain guess work. All we can do is make short term guesses with the information we have at hand and wait/hope for the next piece to be delivered and review whether our guesses were correct or not.
The broker reports have said that while the trial is still awaiting final design approval, the back office is still powering along on time so I don't think the trials will be pushed back unless the final trial design requires more time. So I wouldn't say "can't/won't" start until next year.
So my educated forecast/guess is that the final trial design is complete. It took time as they engaged with the FDA and were given assurances that a trial such as the EMA trial would be considered by the FDA to get full FDA approval but the FDA had a few items included/augmented etc or needed the trial outcome needed to show particular data points if the EMA trial was to be used for full FDA approval. This clearly take a high level of expertise in all aspects of the trial. This takes time and money. ANP don't want to raise more or less funding than necessary. Both have negative consequences. So it's important to get trial design final approval to know exactly how much they require. I think this is where ANP are now. The numbers are there and they have various funding solutions from a wide variety of investors. When they get the green light from the PDCO (which is not guaranteed yet) they can explain the final approved plan to investors and shareholders and see who stays and who goes as the final plan may not suit everyones budget, plan, timeline, outcome etc etc.
As far as toxicity goes, the EMA requirements have been met so the trial will include increased dosing. The trial is planned for 12 months so there is time to consult further with the FDA to get more guidance or acceptance on using data from the human trial to meet the toxicity requirements of the FDA. But right now, the only option on the table is the monkey toxicity. The whole FDA toxicity issue will come down to the progress of the EMA trial. I am not expecting to see, nor do I want, ANP to begin a costly monkey trial while they have human subjects providing the real life data. If this drug begins to show success in Europe, I expect the FDA to reduce the requirements for toxicity. Not because it's invalid, but because it extends the timeframes for drugs getting to patients. The FDA would not like to see a drug become available in Europe, while they have nothing available on home turf until a monket trial is completed. The FDA are well designed to get drugs to patients quickly. Fast track designations, PRV etc is just 2 methods they use to make drugs available faster and easier. On the other hand, if we see the monkey trial commence during the EMA trial, I would begin to consider that the drug isn't as effective as they hoped. Perhaps .....
Naturally, my next thoughts are funding. Specifically, who and how. I've mentioned this before but money isn't just money. $30m from a hedge fund vs $20m from a big pharma vs $40m from instos and shareholders all communicate a different message from management. Think about how the shareprice would react if big Pharma like Moderna or Astra Z picked up the entire raise and a big piece of ANP ? What about a private equity ? What about licencing agreements with untargeted jurisdictions ? What about Aussie Instos ? What about current shareholders ? What about a mixture of the above ? What percentage proportions to who ? I'd like hope that we can all get some more in the raise but maybe we won't. In which case, then we should all be buying on market right now. If we do get offered some shares, then maybe things will move slower as shareholders take profits ? Would a big pharma that have taken a close look at ANP, offload shares after purchase ? Would instos ? Would you ? It's a difficult decision but one that a board would be doing a lot of diligence for.
These are big questions which ANP haven't made before. They haven't needed to. But now that they do, I suspect more board changes/additions ahead too. The Chairwomen has a big job ahead, but not one that she can't do. I think the year or two ahead are going to be amazing for ANP, for the patients and for us.
Now going back to my first words, it's about taking the small publicly available pieces of information and trying to forecast the big picture which is hard to do. But as the impending information comes in, which are much bigger pieces, it will become very hard to hide the future of this company and the shareprice will react accordingly. You're either in or your out. Best of luck to all.
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