$PNV have today announced the conclusion of the patient enrolment phase of the BARDA trial (PIVOTAL CLINICAL TRIAL), which started (I recall) in late 2021.

ASX Announcement

It has taken some 3 years to enrol 120 patients with full thickness burns (FTB) sufficient to meet the criteria, although the recent addition of India as an enrolment location has significantly accelerated the conclusion of the trial enrolment process.

It's not clear what the forward timelines are. Presumably, all patients have to progress through treatment to their end point. In the case of FTBs, I understand the primary end point is wound closure after 12 months. If it is required that all patients have to reach this end point, then there would be at least another year before submission of the data, and then around a further year for a Final FDA decision.

However, given that $PNV have repeatedly referred to ongoing dialgoue between BARDA, the FDA and $PNV, and given that many of the early patients will have passed the end point, as well as the repeated references to this in the last three investor presentations, I anticipate that the PMA decision may run to a shorter timeframe.

$PNV have been very disciplined not to say anything about timeframes (although DW always sails close to the wind on this), because ultimately, neither $PNV nor BARDA are in control of this. That said, given that BARDA is a government agency, then that probably counts for something.

Essentially, a FTB on-label indication will likely 1) lead to a BARDA stockpile purchase and 2) further accelerate adoption for FTBs in the US and 3) facilitate approval for FTB in those countries where FTB is not yet an approved indication. Note: it is used for FTB in many countries, and is already used for this off-label in the US.

Given all of this, the announcement is not price sensitive.

That, at least, is my understanding. Happy to be corrected by any StrawPeople who know better.

Disc: Held in RL and SM