Hi there
I don't believe something being declared a public health emergency in the US automatically allows the FDA to start issuing EUAs. I believe the Human and Health Services (HHS) in the US must firstly declare a public health emergency, which then allows the federal government to use certain powers (such as issuing new EUAs), but that is a separate step which I haven't seen taken yet by the US Federal government/HHS.
2018 status of HHS response to opioid public health emergencyWhile a little dated, the above article summarises what the Federal government/HHS has done in response to the opioid public health emergency and while it does mention that it looks to expedite support for research on treatments against the opioid crisis.. it doesn't directly say it authorises the FDA to issue EUAs (which they did for the COVID-19 pandemic).
I think the Opioid crisis in the US is going to be extremely difficult to address.. and it's going to take a very long time before it gets under control. Right now, the focus has been on the treatment of opioid addiction and saving those who are having an opioid overdose.
Naloxone is an approved drug that is highly effective in reversing an opioid overdose... Methadone and Buprenorphine are opioid maintenance drugs, which help those recovering from opioid addition to break the addiction.. they are commonly used along with Naloxone but the scary this is that not all doctors in the US can prescribe these, they need a special waiver. No such waiver needed for opioid prescriptions though.. they fly out the door!
These are really band-aids for what is an open wound that is eating away the body from the inside out... what the FDA really need to do, and I can only hope they are genuine about it all, given they have issued guidance in October last year providing guidance on how sponsors should design trials to address opioid addiction i.e. opioid sparing treatments. Because they know they need to start addressing the opioid crisis at the source of the problem.. rather than looking for more band-aids. But nothing has been as effective as opioids at reducing pain.. well of course until this CLBP trial result that MSB have in hand where MPCs have had an amazing response to pain reduction and opioid sparing with 40% coming off opioids after 24 months, under instruction to
not change their medication.
But while we do our research and feel that there is a strong reason for the FDA to take a certain stance or make a certain decision... ultimately it is up to them and we can only make educated guesses. From what I've seen, I believe that Mesoblast have had two amazing phase 3 trials for CLBP and CHF, where a single injection of rexlemestrocel-L into CLBP sufferers saw substantial reduction in pain, especially those who have had CLBP for less than 68 months (p value = 0.0001) at 24 months, with a 40% reduction in opioid use at the same 24 month time point.. and where a single injection of rexlemestrocel-L was injected into the hearts of CHF sufferers, for class II patients they saw a reduction in stroke, heart attack and cardiac death p value =0.009, as well prevention of disease progression to class III.
Not to mention what they've achieved with remestemcel-L on COVID and SR-aGVHD...
At the end of the day, if non of these treatments worked.. you simply would not see results like these... and to see these consistently across disease types, is not a coincidence. Rather it can be traced back to their proposed mechanisms of action and while they were not able to select the correct endpoints and/or patient populations across all these trials (bar SR-aGVHD), they now know for all indications mentioned above.. what their target population is and what endpoints they should be using.
For that reason, I am willing to put my money where my mouth is and hold and accumulate with the belief that the FDA will see these treatments for what they really are and that big pharma will not let these treatments simply fail and disappear. Nor will the industry, which is why we are seeing US$100m in capital coming from surgeons who want to see these treatments hit the market.. they want Mesoblast to succeed. So in my mind, the products work and one day they will become available treatments for all humans, even those who spend their days trying to discredit this company and what they are trying to achieve.
Goodluck all
(20min delay)