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It seems you know more than most, but FYI, Leo has answered several emails. As a matter of fact, I have found many CEOs of companies this size quite good about responding to shareholder emails. And not one has asked how many shares I own.
Dobro sam. Maybe one can't generalize, but I can tell you from my experience with following several companies in clinical trials, months and even years can go by without any news on any progress or even whether enrollment is moving along. Maybe p21 expression would be considered material, but surely enrollment would not be material, IMO.
Gov: my question, too. What is a material event? I think that it could be argued that p21 expression is not. However, I'm not a lawyer or SEC pundit. Like Cabel,I also had written to Leo about another matter and have not gotten a response. Seems like he is being very quiet. I am wondering whether he had to agree to some sort of news blackout at DF's request?
Absolutely agree. If one were to read Leo's email resaponse to The Progressive:
It would appear that he, too, is confused about what may and may not be disclosed prior to and within the poster presentation. Otherwise, why would he be concerned with the ASCO rules about lab results which, according to many on the board who have even graciously provided links to ASCO rules, would not prohibit announcing lab results of the ongoing study, nor would it allow for the release of those results in the formal presentation at the conference?
Dr. Feelgood, have a martini and breathe :) I appreciate your efforts to clarify.
Thanks to Doc and all for trying to clear up the ASCO/news confusion. I may still be confused, and probably not the only one, but maybe.
I think that I and others had viewed an ASCO presentation as a juncture where new data may be revealed in the poster (Q&A notwithstanding). However, it seems that no interim results from an ongoing study can be included in the formal presentation.
If SO, my QUESTION is: Will the CTIX presentation most likely be information that we who follow the trial are already aware of? Is the purpose of the presentation to promulgate the trial itself to others in the field? And, why do shares experience the ASCO bump if no new news is generally presented?
p21 transcription question: Leo spoke of the tests for p21 expression being conducted mid-March. Some on the board questioned whether these low dosages would be enough to show an effect in p21. Elsewhere, it was pointed out just how expensive these p21 tests are to run. So, the question I ask is why would DF choose to run such an expensive test at a relatively low dosage? The obvious answer would be that they expect to see something. But, can anyone propose a less-obvious answer? Is the test that sensitive that it would detect very small changes in p21 levels?
So perhaps the strategy is to fasttrack Kevetrin via an unmet need route in the treatment of retinoblastoma and then let the tail wag the dog, as it were.
Sorry for being obtuse, but at first I believed that MSK had the drug and the company was might be obtaining a license to develop it. Reading the filing, it seems that we have the drug and MSK might purchase the license. Anyone whose first language is English can help please?
Any educated guesses as to where dosing stands? I've lost track. The first cohort began their dosing early November, and, at the time, Mr. Ehrlich described them as having few months to live. Any inferences? TIA
Question about the delay in completion of cohort 2: Are the two other patients in the cohort forced to wait until the third is dosed? It seems so. And if it is, what of their weeks without any dosing? There must be one point of view that repeated dosing is useful, otherwise why continue cohort one on repeated dose? I suppose that there could be a comparison made later between those who were in continuous treatment and those that had an interruption.
Also wonder whether Dr. Menon says March for p21 data because they need to get final data from this uncompleted cohort?
Many trials fail in PhIII. In some cases, and I don't know abot C___, fortunately wasn't in it, the PhIII trial is a larger trial in order to achieve statistically significant results. May be other more stringent requirements as well. PhII may have been promising but just didn't deliver stat. significance needed.
From FierceBiotech: "About a third of all Phase III studies end in disaster. The analyst Tim Anderson recently produced a report pointing to a 65% success rate, which is down from the 70% success rate tracked just a few years ago."
Yes, I thought not, Just responding kindly to the post that had misinterpreted the PR as Kevetrin working in humans. As I said, to me this is bigger news that the market reaction would indicate. First, a corroborated result in an outside lab. And, maybe more important, the mention in the PR that "Cellceutix has provided the requested information that will be used to investigate a Specialized Programs of Research Excellence (SPORE) grant for a phase 2 clinical study." A Phase 2 study - bypassing dosing and safety, I'd presume, because Leo &CO. know that safety will not be an issue. i.e. The DF trial is on target. And, since I rarely post, let me take this opportunity to thank you, TOB, and the other dedicated DD researchers on the MB.
I'm sure I will be corrected if I misunderstood, but I thought that the BIDMC trials were animal studies. In Vivo could be human, but is more likely animal. Being the PR refers to cell line 786, I'd presume those are cultured cells. Nonetheless, excellent to see these results reported by an outside study!
Dr. Thank you for your explanation. One reason I asked about this is my familiarity with another drug trial, albeit very different MOA, for head and neck cancer for a drug called multikine. In that trial, it is being administered before SOC while the immune system is still intact. I was simply wondering whether Kevetrin might behave differently pre and post radiation and chemo. Not trying to make a point, as another poster seemed in infer. Just asking a question.
Thank you Gov. But more specifically, radiation and chemotherapy have terrible side effects, as we all know. They include virtually shutting down the immune system. My question is whether Kevetrin would work differently in patients who haven't had their immune systems attacked by chemo/radiation?
That's why I asked whether the animals had undergone any prior treatment before Kevetrin.
Not sure if I am being clear. I apologize in advance and thank you for your reply.
Question from new poster, old CTIX holder: I am wondering about the animal trials on Kevetrin. Does anyone know if the animals had undergone any chemo or rad Tx prior to treatment? I am not a scientist and don't know if Kevetrin MOA might be different in immunocompromised individuals vs untreated. Maybe an MD among us has an idea of this.
The reason I am asking is because I wonder if Kevetrin would work differently if administered prior to any other treatment. TIA