update:
02/03/2021
as already flagged, a big win!
I have bought in at $4.40 (bit late to the announcement!)
I think this now represents a real sable entry point given the turnaround of the business structure has pretty much been completed. But more importantly if they can execute on campturing the IS pre-hospital market (which is not unreasonable given it is doing that through the rest of the anglophone medical world) then the revenue multiple will be huge. I will try and do some maths when I get free but the US market is likely to be several 10x what they are currently doing
clearly there are risks, but for me an extraordinary asymmetric bet
18/10/2021
This straw was going stale so I thought I'd add a few comments, to update things:
It was a shocker of a year for MVP. Revenue plummeted, they made a 12 mill loss, compared to profits for the previous 7 years. They also had to do a cap raise, diluting shareholders by ~10%. The SP has dropped from a high of $7.29 to $3.21 in July. It is now back up to $4.89 after a recent sharp run up on no news in particular.
They have instituted a turn around plan which mostly involves taking back control of the sales of their primary money earner - Penthrox. This has cost them $9.5mill.
The world is opening up again, people will start to break bones once more in the pursuit of sporting glory or a carbon-free method of commuting to work. The green whistle will begin to provide succour to the maimed. The number of countries that have sales agreements continues to go up and up. The future is bright, the future is green.
Except the US. Still no news from the FDA. MVP are likely to have to run a (very expensive) phase III trial, and also run in it in the US (even more expensive). It's difficult to know how expensive this will be until the design requirements are known, primarily how big it will need to be to satisfy the FDA it is powered to provide statistical significance.
Putting it all together, it is likely that the ROW sales are going to improve and on better terms than previously. I dont think they will shoot out of the starting blocks given that they are going to have to renegotiate all the sales details.
Who knows what will happen in the US. It should get waved through, but it is difficult to see that happening and the phase III could easily take years to design, run, submit and get processed by the FDA before approval. And then they will need to negotiate 3rd party sales conracts or build up a sales network themselves, so meaningful revenue is a hell of a long way away.
The longer it takes the higher the risk of a new innovation, though it too would have to clear the same barriers.
If MVP were still in the 3's I would be buying.
I'm not so sure at the moment. As the old saying goes, "most turn around stories never turn"
18/04.2021
Below is a very recent study of Penthrane in the US emergency setting.
Currently Penthrane is not approved by the FDA despite numerous trials elsewhere in the world and widespread adoption but the rest of the western world's medical systems.
It has been a staple of Ambulance services in Australia for many years, an excellent safety profile, so there is no real expectation that it's use should be declined.....but this is the FDA.
MVP has fallen off most investor's radar as COVID has significantly impacted their business, for a number of different reasons (reduced trauma, difficulty executing sales and regulatory hurdles, changed distribution model
Many of those reasons could reasonably be expected to disappear in the next few months. and there are encouraging signs of increasing uptake in Europe (despite the above factors). Trials are planned for China as well.
There has been recent Director buying.
I do not currently hold
HOT OFF THE PRESS
Free Access
Hot off the press: the RAMPED trial—methoxyflurane for analgesia in the emergency department
Christopher Bond MD
Lauren Westafer DO
Kirsty Challen MBChB
William K. Milne MD
First published: 26 March 2021
https://doi.org/10.1111/acem.14257
Discussing:: Brichko L, Gaddam R, Roman C, et al. Rapid Administration of Methoxyflurane to Patients in the Emergency Department (RAMPED): a randomized controlled trial of methoxyflurane versus standard care. Acad Emerg Med 2021;28(2):164–171.
Associated podcast: https://www.thesgem.com/2021/02/sgem320?the?ramped?trial?its?a?gas?gas?gas/
Supervising Editor: Esther K. Choo, MD, MPH.
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BACKGROUND
Pain is one of the primary reasons that patients present to the emergency department (ED).1-6 Oligoanalgesia is a significant problem and effective pain management is an important indicator of the quality of patient care.7-12 Multiple factors have been thought to contribute to oligoanalgesia including overcrowding, language barriers, age, sex, ethnicity, and insurance status.13-16 Delays in providing adequate analgesia lead to poorer patient outcomes, prolonged ED length of stay, and reduced patient satisfaction.17, 18 Previous research in Australian EDs has shown that the median time to analgesia administration can be between 40 and 70 minutes, while one study in the United States reported a mean of 116 minutes.19-21 To minimize delays, various strategies have been implemented to address the problem, including the use of novel analgesic agents that do not require intravenous access.22
Recently, there has been increased interest in using methoxyflurane (Penthrox), an inhaled nonopioid volatile anesthetic, to provide rapid short?term analgesia.23, 24 In Australia, methoxyflurane has been widely used at subanesthetic doses for analgesia in the prehospital setting since 1975. It has been used more widely recently and at low doses and has a very reassuring safety profile, with no reports of addiction or abuse related to its use.25-28 The majority of studies of methoxyflurane for pain focus on traumatic pain; this study aimed to assess its effectiveness in treatment of both traumatic and nontraumatic pain.
ARTICLE SUMMARY
This is a randomized controlled trial of adult ED patients with severe pain, defined by an initial numeric rating scale (NRS) pain score of greater than or equal to 8 on an 11?point scale. Treatment arm participants were given inhaled methoxyflurane at ED triage and the comparison group received standard analgesic care, which could include acetaminophen, nonsteroidal anti?inflammatory drugs (NSAIDs), tramadol, oral oxycodone, or intravenous morphine. The primary outcome was the proportion of patients who had at least a 50% reduction in pain score at 30 minutes. Secondary outcomes included median pain score at 15, 30, 60, and 90 minutes; the proportion of patients that achieved a >2?point drop in their NRS pain score, and data pertaining to adverse effects.
QUALITY ASSESSMENT
The most notable limitation of this study is the open?label design. There is substantial difficulty in blinding study participants to the use of an inhaled medication (methoxyflurane) that has a particular smell and taste, but the lack of allocation concealment likely biases the results toward the intervention group. Other limitations include the selection bias of nonconsecutive patient recruitment and the exclusion criteria which removed many patients with abnormal vital signs. These abnormal vital signs could have simply been due to severe pain and thus would be an excellent group of patients to study. Finally, only 4% of patients arrived by ambulance in this study, which may not be representative of many hospitals.
KEY RESULTS
Overall, 121 patients were randomized into the RAMPED study and there was no statistical difference in the primary outcome between methoxyflurane and standard analgesic care. In the methoxyflurane arm five (10%) patients had a reduction of pain score by >50% at 30 minutes compared with three (5%) in the standard care arm (p = 0.49). The administration of methoxyflurane was associated with a significant reduction in pain score at all time points and a notable secondary outcome was that the median time to rescue analgesia was longer in the methoxyflurane arm, 66 minutes compared with 46 minutes in the standard care arm (p = 0.024). There were no adverse effects attributed to the methoxyflurane.
AUTHOR'S COMMENTS
In this study of methoxyflurane versus standard analgesic therapy in the ED, there was no difference in pain reduction at 30 minutes. However, methoxyflurane does appear to be a safe and effective additional option for analgesic at ED triage.
TOP SOCIAL MEDIA COMMENTARY
Brent Driscoll: Great rapid analgesic for procedural and visceral pain even better when used in conjunction with opiates. Great synergistic effect. Fell out of favour for a while the excitement of intranasal fentanyl took hold but back in vogue as quick effective relief in trauma while IV access and opiates are readied. The ability of the patient to concentrate and titrate their dosage (“if it hurts, keep sucking”) and that it is self?regulating? if they have too much, they drop the inhaler and nod off is a great quality control. An Australian EMS staple for decades.
Minh Le Cong @ketaminh: It's a great piece of kit imo. I have one in my car kit for roadside attendances. Easy to use and effective in kids and adults. There is environmental contamination of exhaled gas to be aware of. It's like a portable mini nitrous oxide kit.
Julie Rankin @JulieRa00539796: Regular analgesia use for msk injuries in Northern Ireland ? great quick easy effective analgesia.
Prof Tim Hardcastle @vemadoc: They use it for burn dressing changes here. Works well in kids.
Evan Schwarz @TheSchwarziee: This seems to be very popular in countries outside the US. It's nice as no IV required and can be another component of multimodal pain medication whether an opioid is necessary or not.
PAPER IN A PIC BY DR. KIRSTY CHALLEN
TWITTER POLL BY KEN MILNE
TAKE?TO?WORK POINTS
In this randomized controlled trial, methoxyflurane was an effective analgesic agent for severe pain but was no more effective than standard analgesic care at 30 minutes. If available it remains an alternative analgesic strategy to usual therapies.
CONFLICT OF INTEREST
The authors have no potential conflicts to disclose.
