The excerpts below from yesterday's PR refer to the fact that BDD's expertise will greatly help speed up not only the development of the controlled-release tablet but also getting it into clinical trials.
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"We are also delighted to be able to engage BDD’s expertise in gamma scintigraphy and early clinical testing to take the Brilacidin program forward expediently into clinical investigation of the new dosage form,“ commented Professor Howard Stevens, Chairman of BDD Pharma.
From the PR - 'BDD will provide further expertise and resources by collaborating with the Company to accelerate initiation of clinical trials. The trials, evaluating Brilacidin for IBD in tablet form, are targeted to commence later this year or early thereafter.'
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Some have expressed their distaste for the time needed to accomplish getting the tablet into trials but IMO if they do get it into IBD trials by later this year or 1st quarter of 2020 that would be quite remarkable and mgt/BDD should be highly applauded for such an achievement. Remember, they are not only getting the tablet developed (probably the easiest part of the process) but also having to get a P2 protocol submitted and approved as well. All that within the space of 6-8 months would be quite spectacular IMO.
I wonder how long a treatment period will be required for the tablet IBD trials? It would be my opinion that some photos may also in line upon completion of the P2 trials for some, if not all, patients but that may be cost prohibitive at this point. A couple of patients showing dramatic improvement as evidenced in the sigmoidcolitis trial photos IMO would be breathtaking for increasing the value of B for IBD.
So to have OM having a good shot at being in a P3 in 2H 2019 and IBD entering P2 trials around first of 2020 would really be ramping up progress as to IPIX pipeline.
Then throw in money in H2 2019 for Kevetrin pill (no need for customized pill IMO, just a need to get it into the bloodstream as efficiently as possible)to be developed and by end of the year IPIX hitting on all cylinders.
Exciting times!!
