Yes impressive lack of news available to explain increase

Quite a run in the last month, up 95% on no news. No real increase in search volumes on Google Trends as per below so can only assume as @thunderhead mentioned, a rebound from tax loss selling.

I did see today that Netflix dropped 5 days ago a trailer for a new show called "Painkiller". A fictional show on real life events about the opioid crisis in America and the invention of OxyContin. Hopefully raises some awareness and helps in the future with gaining approval in the US - https://www.youtube.com/watch?v=24-YonhNS0Y

Thanks @PabloVic for insights from Google. I always forget that can be useful show of interest from personal investors.

But don’t think it is rebound from tax loss selling of Medical Developments given the share price was pretty stable in May and June, and the decline before that just continued the long downward trend since start of Covid. Maybe Med Dev cactching some reinvested tax loss selling from other companies?? But that still begs the question of why the renewed interest in Med Dev. Hints that it is insider buying, albeit not substantial holders.

@DrPete and @PabloVic are either of you (or any StrawPeople) clear about the pathway for Penthrox approval in the US?

I see references in recent $MVP presentations to "Planning for Penthrox USA market entry underway focus on future partnering potential" and a recent odd annoucement that "MVP formally approved the strategic pathway for commercialising Penthrox in the US. The Company will now commence a search for partner organisations to undertake the clinical and non-clinical programs and to launch Penthrox in this market" but I haven't heard any news about what the pathway is.

Given that Penthrox was banned in the US in 2005 over safety concerns in higher dose uses means that it has already been approved once. So, presumably the pathway is different than an NDA? The "Green Whistle" is a lower dose acute pain indication, and the medical device mitigates risk of overdose (unless I guess you hoard a stock of whistles for abuse!). I'd be interested to know what the pathway to approval in the US is. For example, would they need to conduct a new clinical trial in the US? Or would they be able to report data based on commercial use based on adverse events in the existing markets like Australia, France and UK? Clearly, the partnership strategy annoucement indicates that they are looking for a US partner to prepare the FDA dossier and filing. That would imply that they are some way off a US approval and a next step would be the announcement of the US partner?

I dont know the product well, but presumably a US approval would be a BIG SP catalyst. I've decided not to take a speculative position, because there really is is no indication as to timeline. However, as @DrPete asks, what's driving the recent demand in the market? Is a plan starting to materialise and insiders are taking positions? Or is it purely speculative, with some of the usual pundits talking about the potential? For example, I heard Mathan (Deep Data Analytics) on Ausbiz talking it up a few days ago.

Until now, my investment strategy has been to have it on the watchlist and to take a position the moment the FDA approval comes out, provided I can get it at a reasonable price. Of course, when that happens there'll be a mad rush, but as others have noted, a US market for the Green Whistle would transform the company, and a 30-50% pop on the day might not be a problem, depending on where it starts from.

The announcement of a partner would also likely be a signfiicant SP catayst in itself. This would particularly be the case if the partner was well-credentialled in terms of FDA approvals. The clinical and regulatory people at the prospective partner would want to look at the data $MVP has to form their own view on do-ability before signing the partnership. So such an announcement might therefore also justify an initial entry position.

Disc. Not held

@mikebrisy Think maybe only ambulance drivers could hoard their own stock of green whistles! Maybe that's why I see them sometimes blissfully waiting at Cronulla beach??

In Mar last year US FDA gave go ahead for Phase III trials, which are now underway. 10 sites, 200 patients, cost $12m. Expected to take a couple of years. If successful, Med Dev said registration and commercial launch in FY26.

As for commercial pathway if approved, there was this release in April '23:

Medical Developments International (ASX: MVP) today formally approved the strategic pathway for commercialising Penthrox in the US. The Company will now commence a search for partner organisations to undertake the clinical and non-clinical programs and to launch Penthrox in this market.

CEO, Brent MacGregor said, “We are in the final stages of a comprehensive commercial assessment of the US. Feedback received through this review affirms the substantial opportunity for Penthrox in this market, which is the world’s largest for pharmaceuticals. It is clear that delivering value from Penthrox in the US will be best achieved through the support of one or more partners.”

The hope would be they could leverage an existing distribution network for a cut of the profits decreasing capital required to launch and accelerate the roll out.

3 probably 4 years away. Could announce a partner whenever though (likely sp catalyst) especially if it was a big name.

A mistake here would be to assume they need to be approved and selling the product for the bulk of the value to be realised.

Giving this one a bump/nudge a week on from the last post.

Medical Development International Limited (MVP) were issued with a 'Please Explain' from the ASX today regarding their recent SP action (opposite of a speeding ticket - not sure what that is called).

The company released a fairly straight bat response here.

I've recently taken a position in MVP on SM only, to begin to watch this one closer and in an effort to pay more attention to their announcements. They're currently on my watchlist as a potential long-term play.

Understand the SP is going to fluctuate dramatically from time to time by nature of the business, however if they can execute (and get approval) I can see this is being a good play over the next 5+ years.

Continuing to watch from the sideline IRL, but showing interest through adding to my SM portfolio.

Intelligent Investor issued a "Sell" recommendation for MVP yesterday which appears to be contributing to the SP tanking after its equally brief post-EOFY no-news rally.

Yes, I think the II crowd is responsible for a big portion of the recent selling.