Wow, a lot of interesting posts lately. This one will seem dull by comparison but at least it has a different focus for those that need a break from the other stuff.
I reviewed the 10Q and noted a couple things not mentioned by others:
1) I really liked BK's post 52417 providing a succinct and (to me) plausible timing scenario for the ABSSSI Brilacidin trial . We are all dealing with incomplete information but BK's timelines seemed quite doable and realistic as opposed to some other projections which had the trial over in a month because of the short dosing involved. The bottom line of his post is that he projected completion of the B trial near the end of 2014. Again , seemed quite reasonable to me and I kind of built that timeline into my way of looking at B. So I was surprised by this information from the 10Q:
"The FDA therefore supported the use of brilacidin in an upcoming U.S.-based phase 2b clinical trial comparing three short-course regimens (two single-dose regimens and one 3-day regimen) to an active comparator, daptomycin. Similar to the previous trial, the study is to enroll approximately 200 patients (50 patients per arm). This trial received IRB-approval in early January 2014 and is scheduled to begin enrollment in 1Q 2014, and to conclude enrollment by the end of 2014."
If this is the case then enrollment will not be wrapped up until the end of the year. Then comes the rest of the study, which if you like the rest of BK's projection puts trial wrap up at mid 2015. I wonder why the enrollment will talke so long ? Any ideas? With 75,000 patients with the condition per month (per BK's post) it seems that roughly a year of recruitment is pretty long. I guess I will have to adjust my timeline to mid 2015 on this trial.
2) There has been some discussion we should hear soon about SPORE grant awards. The 10Q says this:
"Results of these preclinical tests provided to date to the Company are encouraging and BIDMC and Cellceutix wish to move the study further. Cellceutix has provided the requested information from BIDMC that will be used to investigate a Specialized Programs of Research Excellence (SPORE) grant for a phase 2 clinical study of renal cancer upon completion of the successful phase 1 clinical study presently in progress."
If I am reading this correctly it seems to indicate there will be no application for a Spore grant until after the Phase 1 K trial is complete. Accordingly, I have taken that item off my list of potential catalysts for this year.
3) There has been a lot of discussion regarding governance and a BOD. This is from the 10Q:
"In an effort to remediate the identified material weaknesses and other deficiencies and enhance our internal controls, we plan to initiate the following series of measures when we have the financial resources to do so:
We will create a position to segregate duties consistent with control objectives and will increase our personnel resources and technical accounting expertise within the accounting function.
Management believes that the appointment of one or more outside Directors, who shall be appointed to a fully functioning audit committee, would remedy the lack of a functioning audit committee and a lack of a majority of outside directors on our Board. "
My take is that this is governance issues are on the back burner especially in light of the section noting the considerable expense coming up for trials. There also was a mention elsewhere in the document that some additional staff was hired for the accounting deficiency but it was not adequate to fully address it. All that said, it probably is not the best time for this young company to shoulder the expense involved in resolving the BOD and material accounting deficiencies. Leo has been upfront on this in a number of previous filings but I do not remember a specific reference to inadequate financial resources until this filing but I did not go back to check. The bottom line to me is that talk of any appointment of a BOD occurring in the near future appears premature.
AI
