Quote:Look at EDSA, little company , halted for efficacy, stock runs up 1 day and they are back in the dust again.
It was foreseeable as I said on 9/20 the day before it came back down to earth.
Quote:Took a very quick look at the company low burn rate but also low cash on hand. Not a big problem there.
The run up was based on the press release of recovery for ECMO patients. Very small patient population and SCO was dexamethasone and IL-6 inhibitors which have shown little benefit in ECMO so easy to beat. I would put effectiveness on par with lenzilumab and I gave that a 50/50 chance of being approved.
What makes me wonder is out of 198 patients at the interim why 33 were on ECMO. The trial accepted patients that were level 3 (no oxygen) to level 6 (mechanical intubation or ECMO). With more available patients at the lower levels that's where you'd expect the preponderance of patients (as in CD12). The trial also excluded those who were on mechanical ventilation or ECMO for 5 days or longer further narrowing the potential patient pool. It looks like the deck was being stacked towards critical patients.
Of interest is that they released the interim for ECMO and critically ill but not the rest of the patient population. Critically ill mortality at interim is p = .15. Expected mortality for full phase 3 would be p = .75 still not statistically significant. That numbers weren't shown for the full patient population means the results were almost certainly worse.
With the small market cap there may be a further run up. But the FOMO based on the PR is overexuburant and overbought given the actual interim results. I would expect that realization will eventually dawn and there will be a pullback on the price. If I was in I would be monitoring the price like a hawk and sell on the start of a retraction. Better to lock down the profit on a nebulous upswing and potentially buy back in lower if you're confident of an approval.
Before I'd even hazard a guess to whether it's a long term hold I'd like to see the full data. If they are searching for an EUA they'd almost certainly have to change the protocol to ordinal scale 5, 6 only (high flow oxygen to ECMO).
5
