Replies to post #18011 on Cel Sci Corporation (CVM)

[William71]

Like your post and agree with the exception that short sellers don't invest out of hate. I think the stock is flat on very low volume because the CRO that received shares last week is selling. Can't think of anyone else.

[M_P_J]

Interesting response on the Yahoo board:


Marc20 hours ago
Here's the issue Fuerstein was talking about. From CVM's 2016 annual report, the 2 negative communications from the IDMC:

"Throughout the course of the Phase 3 study, an Independent Data Monitoring Committee, or IDMC, has met periodically to review safety data from the Phase 3 study, and the IDMC is expected to continue doing so throughout the remainder of the Phase 3 study. At various points in the study at which the IDMC has completed review of the safety data and has issued recommendations, it has recommended that the Phase 3 study may continue, although on two occasions the IDMC has issued recommendations that would have closed the study entirely (spring of 2014) or at least closed it to accrual of new patients (spring of 2016). On one occasion, in the spring of 2014, the IDMC made a recommendation that the study be closed for safety and efficacy reasons. However, following review of additional information submitted by us, the IDMC recommended that the study may continue. In the spring of 2016, with close to 800 patients enrolled, the IDMC made a recommendation that enrollment in the Phase 3 study should stop, but that patients already enrolled in the study should continue treatment and follow-up.

Here's why I'm not worried. In March 2014 the 33rd patient was enrolled in P3. At that time a total of 5 patients were 6-months past the 21 day MK period, and probably only 2 of them actually received MK. There were maybe 15 patients total who had received MK, some of them a matter of weeks prior. If even one of those patients had a negative result that would be statistically insignificant, but would be cause for the IDMC to have concerns about the study continuing. The fact that the study continued and the IDMC dropped its concern tells me there was likely an anomaly early in the study. At the time of the IDMC's first negative communication it was simply not possible for there to have been evidence that MK would fail.

The 2016 IDMC recommendation came when fewer than 33 patients had been in the study for 2 years. The IDMC recommended to close the study to accrual of new patients but did not mention safety as an issue. This seems to be more of a concern about the study design (irrespective of MK's results). The FDA put the study on partial clinical hold and cited unreasonable risk of harm, but for that they cited CVM's failure to promptly report the IDMC recommendations. The FDA wants that information ASAP so it can protect patient safety, so anybody not promptly reporting to the FDA poses a risk to patient safety. The FDA was pissed about not being told what's going on because that could lead to harm, it does not mean the FDA had any data to suggest that patients would actually be harmed from MK. The FDA also cited issues with the investigator brochure, and said CVM's plan is deficient in design to meet its stated objectives. We know Geert has said people in the study weren't dying as quickly as expected, and this is why CVM tried to add more patients. The FDA's action in 2016 was a decision that CVM does not need to add more patients, and that the study can continue.

2016 does not concern me at all, at least not from the standpoint of MK's performance, because none of the issues related AT ALL to MK's performance. That just wasn't mentioned. The IDMC's 2014 letter sounds bad, but considering how early it was, how few patients were around, and the fact that the IDMC never again pointed to data as a reason to be concerned about safety has convinced me that there was possibly an unfortunate anomaly in 2014 that isn't representative of what happened thereafter. Maybe 1 of the first MK patients died during the 21 day treatment - that would entirely explain the 2014 communication from the IDMC.

So Fuerstein is wrong because there's nothing reported in the 2016 annual report that indicates MK will fail. There was potentially a bad result with one of the first handful of patients on MK in 2014, but those concerns disappeared and did not reappear over the next 4 years when another 350 patients received MK. The only other concern is study design, and right now all we know is the FDA allowed the study to continue. If the design or execution of P3 was so bad that MK couldn't be approved, why didn't the FDA shut it down and tell CVM to start over? It's not just that patients had already been treated so they couldn't be harmed, that's not a reason for the study to continue. If this study couldn't result in MK approval then by allowing it to continue the FDA would be setting CVM back 2-3 years. Had the FDA shut it down for poor design, CVM could have started P3 over again. Since the FDA allowed it to continue I'm confident approval is possible.

The Fuerstein hit piece was a very disingenuous representation of the IDMC issues. The study may ultimately fail and he'll say he called it, but he's 100% wrong to say that is a forgone conclusion based on the disclosures in the 2016 annual report.