Maureen, you obviously have a great deal of courage! To openly comment on a message board on a subject which you appear to know next to nothing is fascinating. Let me explain: The study is designed to obtain approval all over the world, including the U.S. The FDA hold, data review and then removal of the hold PROVES the FDA sees it that way also and that there is a LIKELIHOOD of approval. Also, how can anyone gain approval earlier when the approval data requires the death of 298 patients as a baseline. Why do they not die faster? 1) they are not all terminal 2) Multikine is working and delaying their demise. It is not helpful to this community when individuals make comments on this board who have no idea what they are talking about.
Kyle sure is a slippery one.
The Cel Sty agent continues to claim that the entire safety and lack of efficacy issues with Multikine were due to inVentiv.
Yet, the Multikine IDMC reiterated its concerns over pateint safety in the Spring of 2016. And to ease its concerns the IDMC recommended clsoing the trial to new enrollment. inVentiv was fired in 2013. If inVentiv were the problem, then the IDMC would not have reiterated its safety concerns two years after inVentiv was fired. And closing the trial to new enrollment would not be a remedy to safety concerns due solely to inVentiv's management of patients!
Also, Geerty has insisted that the inVentiv patients were so mismanged that the data from them is unusable. Geerty in his protocol amendment proposed tossing those 125 patients and replacing them. Now Geerty says, 'never mind, I don't need to replace them!' If Geerty's allegations have merit, why wouldn't Geerty want to do that since not replacing them would either 1) reduce the power of the Multikine trial to show significance if those patients were just excluded from the analysis (make it harder to hit its endpoint of a 10% improvement in survival), or 2) if included, make Multikine look worse than it is, which also would endanger it hitting its primary endpoint.
If Geery's allegations had merit and FDA was in agreement, then FDA would certainly allow Geerty to replace those patients. And if FDA allowed that, it would sbstantially bolster Geerty's arbitration case.
Yet geerty pulled his proposal to replace th inventiv patients, thus undermining his allegations that inVentiv mismanaged them and increasing the risk that Multikine would fail to hit its primary endpoint. Why would he ever do this?
The answer is simple: FDA will not allow him to dose any more patients with Multikine.
Okay can someone tell me why big decline if we are moving forward with FDA .. Kyle, Anthony, Michael or any pumper.
Attention, needful: See the S1 filed last Friday afternoon, after the market close.
It registers shares due to Geerty and cronies who bought a convertible note to keep this scam afloat, so the rats can pay themselves.
"By means of this prospectus, a number of our shareholders are offering to sell up to:
● 539,300 shares issuable upon the conversion of promissory notes;
● 539,300 shares issuable upon the exercise of our Series NN warrants;
● 1,532,368 shares of our common stock which are issuable upon the exercise of our Series GG through LL warrants and our Series OO warrants; and
● up to 480,000 shares of common stock which we issued in partial payment of amounts we owe to a firm for services provided in connection with our Phase III clinical trial."
Since the warrants might or might not get exercised, Cel Sty might or might not receive any proceeds from the offering. Translation for needful: far more dilution is coming your way soon!
(I'd warn the yanker, too, but he's most likely hunkered down in his basement under a mound of tinfoil hats to ward off the evil efffects of today's eclipse!)
Watch for the ongoing financing to be announced in typical Geerty fashion: a late summer Friday after the close!
Insiders selling: Form 4s indicate that Eyore Talor sold ~14,000 shares between $2.58 and $2.82 and John Cipriano sold 17,109 shares (about one-quarter of his holdings) at $2.52.
I guess they both expect Cel Sty's share price to soar after the arnitration decision! Hahaha!
Anthony. Forget FDA. Out of the 880 patients very few enrolled in US. Geert has said over and over MK will be approved overseas. It has been over thirty years not one country has approved MK. What does that tell you. The trial would be a year old in Sept. and not a word.
This is why CVM is significantly undervalued and what the geniuses on this board do not understand. The following is taken directly from the FDA code of regulations. It states explicitly that a primary objective of a Phase III hold is determining the likelihood of a drug gaining approval! TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION
Subpart B--Investigational New Drug Application (IND)
Sec. 312.22 General principles of the IND submission.
(a) FDA's primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety. Therefore, although FDA's review of Phase 1 submissions will focus on assessing the safety of Phase 1 investigations, FDA's review of Phases 2 and 3 submissions will also include an assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.
WEBLEEDBOOZE IS UPSIDE DOWN ON THIS STOCK. HIS ANGER, RESENTMENT AND HOSTILITY SHOULD BE DIRECTED AT THE PERSON HE SEES IN THE MIRROR. LASHING OUT AT OTHERS IS NOT THE ANSWER. ABSORBING HUGE FINANCIAL LOSES BECAUSE OF INCOMPETENCE IS PAINFUL. MOST PEOPLE SHOULD LET INVESTMENT PROFESSIONALS HANDLE THEIR MONEY BECAUSE THEY ARE UNFIT TO DO SO. YOU MAY LOSE THE REST OF YOUR MONEY HERE. THINK CAREFULLY BEFORE YOU PROCEED.
THIS BLEEDING PIG IS ALMOST UNCONSCIOUS.
THE STREET IS NOT BULLISH ON CEL-STY. OH WISE ONE, LOOK AT INSTITUTIONAL OWNERSHIP. LOL. JOKE. EMBARASSMENT.
SOMEBODY JUST DUMPED A BUNCH. DO THEY KNOW SOMETHING?
ANTHONY SPEAKS: "MOM, WHY AM I STILL LIVING IN YOUR BASEMENT, I'M ALMOST FORTY YEARS OLD. WELL, I'VE MADE LOTS OF POOR DECISIONS. ON THE FLIP SIDE, THERE ARE NO WINDOWS DOWN HERE AND THE WORLD THANKFULLY CAN'T SEE WHAT I'M DOING."
OMG, LOOK AT THE NEW SEC FILINGS IN AFTER HOURS. MILLIONS OF NEW DILUTION SHARES COMING TO MARKET. THIS JUNK IS A DILUTION PONZI
“No new enrollment, no risk of further injury!”
I don’t think so Johnny!
The problem has never been with MULTIKINE! The problem has always been with the TRIAL ITSELF!
Do you want to know why the FDA thought the TRIAL put patients at risk? Look no further.... look at why CEL-SCI is suing inVentiv:
"(i) failing to ensure site selection and patient enrollment milestones were met; (ii) proposing, vetting, and contracting with unqualified study sites; (iii) assigning inexperienced managerial personnel that were not dedicated solely to the Phase III trial; (iv) insufficiently training study site personnel; and (v) recklessly abandoning its contractual obligations, professional standards of care, GCP [Good Clinical Practices], and FDA regulations in managing, supervising, and monitoring the Phase III Trial." (ASOC ¶ 416). Furthermore, CEL-SCI claimed that Pharmanet did not keep accurate medical records; failed to keep information confidential; and failed to "meet any standard of expert care"; injected Multikene in the wrong dosage into patients, in the wrong location, and to the wrong patients; failed to perform required biopsies; backdated records; failed to report patient deaths; and that its conduct "fell below any acceptable standard of care and professionalism." (ASOC ¶ 14-16).”
These issues are the reason the FDA stated that patients already enrolled in the TRIAL were at serious risk. (WHICH HAS NOTHING TO DO WITH THE PROTOCOL AMENDMENT TO ENROLL MORE PATIENTS)
So if these are the reasons why the patients were at risk how did Geert get the Hold lifted?
He provided the FDA with what they requested:
“provide a list of major protocol deviations, which CEL-SCI believes will affect study results, and provide a plan to identify major protocol deviations across all patients enrolled in the Phase 3 protocol.”
Don’t let Johnny fool you. The problem is not with Multikine! The problem was with the TRIAL itself!
The best part is Geert has already managed to replace most of the inVentiv botched patients! 880 minus 928 equals 48 patients already replaced! With 48 extra patients enrolled the FDA has decided to lift the HOLD!
Fraud is imploding, meanwhile Yank Me is doing taint kisses for free. It's a messed up world.
This is sitting right where it opened at after the last RS......... So after what should be really good news and a big upswing and prolonged stay it's back to being the dog it is. SAD..!! back stabbing pigs..!!
OH NO!!! DROPPING EVEN MORE AFTER HOURS.
HOW DID THIS STOCK GET WHERE IT IS TODAY. IT'S QUITE LIKELY THAT THEY HAVE A PRODUCT THAT DOESN'T WORK.