Facts Over Fables, Polarean’s Real Story15 Sep 2025 08:39
Morning all,
Some of you keep repeating the same myths, calling it a failed Phase III or saying it is dead in the water, but that is simply not true, Polarean already has an FDA approved product, Xenoview ventilation imaging was cleared in December 2022 and the label expanded in June 2025 to include children from six years old, that is progress, not failure, the current project is gas exchange, which is a new indication, not a rerun of the past, it is an expansion, not a retry, so maybe read the RNS before posting bedtime stories.
The Phase III protocol for gas exchange was formally submitted to the FDA in August, the company requested Type C written feedback and the FDA response is due in Q4, until that feedback is received no patients will be enrolled, that is how it works, that is the clear sequence of events, and shouting “where’s the trial” every week will not make the FDA move any faster, it only makes you look like you failed biology class.
Sales are slower than hoped, but the company itself flagged budget headwinds in its May results and guided that orders will be weighted to the second half of the year, that is not my opinion, it is their own published guidance, if you want to argue with it take it up with the CFO, not with me.
Funding will be required, of course it will, this is biotech, trials do not pay for themselves, the route will be either equity or a strategic partner, neither scenario is new or shocking, and frankly it is better to secure cash properly now than run on fumes later, only in chatrooms do people act surprised that companies need money to run clinical trials.
So if you want to panic at every red tick, that is your choice, but do not dress it up as clinical insight, the facts are clear, ventilation imaging is already on the market, gas exchange is on the cusp of FDA feedback, and if approved it widens utility considerably, that is the story, everything else is noise, or as Ricky Gervais would put it, hecklers in the cheap seats, shouting over the band, without even reading the program notes.
IMHO and DYOR
ST