Jul. 23 at 10:53 AM
$SLS the entire purpose of bear posts like this is to scare new investors into selling. Those of us have been here for a long time tend to ignore these posts and are completely un persuaded. The purpose of this response is for the benefit of the new investors who are the targets of this nonsense.
First of all with a username like Seedy do we really need to say more? Seedy is pretty much exactly what the content is of this userâs substance.
Seedyâs âhigh probability of failureâ thesis is a house of cards built on a foundations of quicksand - a sea of assumptions being presented as facts. They are no such thing.
First, Seedy is assuming the BAT arm of Regal is dramatically outperforming because the trial has taken longer than expected. Nonsense.
Regal is still blinded. Nobody outside the IMDC knows whether the longer survival is coming from GPS, BAT, or both. Saying âthe control WILL outperformâ isnât analysi - itâs speculation. ïżŒ Moreover the historical studies of how BAT performs ïżŒ and maintaining remission or not on CD side, they cut the other way and demonstrate that these drugs do not maintain remission for long periods of time, especially at the CR2 stage. Indeed, when the leading BAT drugs in Regal, Ven/Aza were put through a phase 3 clinical trial for AML remission maintenance, the manufacturer HALTED the trial midstream - citing low enrollment.
Surely,
$ABBV a major pharmaceutical company with every financial incentive for this trial to finish if it were to be successful and put these drugs on the market for CR two maintenance couldâve and wouldâve solved this problem if it thought the trial would be successful.
Second, Seedy completely ignores the evidence that supports GPS while highlighting only the negatives.
The Phase 2 AML CR2 study for GPS showed survival that was several times longer than historical controls and is the entire reason Regal exists. Does that guarantee success? Of course not. But pretending it never happened isnât an honest review of the data. It is nothing but bear FUD.
Seedy also treats every prior GPS study as a âfailure,â which simply isnât true. Several studies demonstrated strong WT1 immune responses and encouraging survival signals but were small, early-stage trials that werenât designed to prove efficacy. Thereâs a huge difference between ânot statistically definitiveâ and âthe mechanism doesnât work.â
Seedy also ignores the growing body of evidence that WT1 vaccines can generate meaningful anti-leukemia immune responses. The recent pediatric WT1 vaccine study produced excellent long-term survival and showed that patients who mounted an immune response lived dramatically longer. Different study? Yes. Different vaccine? Yes. But it directly contradicts the claim that WT1 vaccines are biologically incapable of working.
Seedyâs statistical argument is misleading too. Heâs acting as if Regal was designed with âno cushion.â Thatâs not how clinical trials work. The 0.636 hazard ratio in Regal which defines success is simply the statistical hurdle needed to declare successânot a prediction of where GPS will actually land.
Finally, if the bear case is so obvious, why has Regalâs independent Data Monitoring Committee repeatedly allowed the trial to continue? They have seen the unblinded data. They stopped neither for futility nor for safety concerns. That doesnât mean Regal will succeedâbut it certainly doesnât support the claim that failure is virtually inevitable.
In short, Seedy tortures the evidence and does gyrations to back into his conclusion that Regal will fail. His calling failure a âhigh probabilityâ while ignoring the strongest supporting data, dismissing positive studies, and presenting speculation as fact isnât objective analysisâitâs cherry-picking.
There are no guarantees in any phase 3 clinical trial. Regal included. But at least to me, Seedy has presented nothing making me believe that Regal is going to fail. To me the evidence points strongly the other way.
To me there is no super BAT and the incredibly long survival of approximately 40% of the Regal patients a minimum of 28 months to move four years cannot be explained by BAT.
Finally, are Pharma Bro and âSeedyâ the same person? I donât know that, of course. But it certainly wouldnât shock me. Once a convicted securities fraudster with a LIFETIME BAN from the pharmaceutical industry always a securities fraudster.
Of course, this is not financial advice and do your own due diligence.
