RE: Looking a Bit13 Jan 2023 19:40
Nice to see the SP holding up when indicative sells far outweigh indicative buys! Was bound to get some profit taking!.
MM’s have been happy to take on stock though with a rising SP. That’s usually a good sign that they will sell back higher.
I am still in the way undervalued camp and see this as a good time to take a position ahead of the FDA announcement(s).
Todays move will obviously have been noticed by the BoD, one would hope they would like to build on this momentum asap.
Here are a couple of key paragraphs for those looking in.
“ The FDA 510(k) submission is the first step in potentially transforming the global GBCA market and introducing a paradigm shift in radiology departments. Eliminating the need to intravenously inject GBCAs, without compromising the diagnostic quality of MRI exams, has the potential to benefit millions of patients annually. Patients with reduced kidney function who cannot tolerate GBCAs, children, and others where there are concerns about the potential effects of gadolinium retention in the body are particularly relevant to the availability of a zero-dose alternative.”
“ This technology is targeted at the multibillion-dollar global MRI contrast media market offering cost, convenience, and alleviating safety and environmental concerns. The initial 510(k) application followed the Traditional 510(k) pathway. Under this pathway, the sponsoring company identifies a previously FDA cleared "predicate" device and uses the attributes of that predicate device to demonstrate "substantial equivalence" for the new device. The FDA has now determined that the patented artificial intelligence (AI) technology contained in IB Zero G is a novel, a "first in kind", such that no currently cleared device exists that can serve as a predicate to establish substantial equivalence.”
“ Our sponsorship of the Phase I clinical trial at the Medical College of Wisconsin Cancer Centre ("MCWCC") continues. Under phase I trials, new agents are studied for safe dosing levels to be used in phase II trials. Screening activity is ongoing and those patients who meet the study's inclusion criteria are invited to participate. Thus far, the enrolled subjects are tolerating the agent well and are remaining on the treatment...”
“…The screening and enrollment of subjects continue at an outstanding pace, and follow-up visits are increasing as more subjects remain on the study. In late 2022, an Orphan Drug Designation application for GaM was submitted to the US Food and Drug Administration (FDA). The FDA has 90 days to review the application. If granted, Orphan Drug Designation provides exclusive marketing and development rights, tax credits for clinical trial expenditures, and potential decreased wait-time for drug approval.
IB's products are used by clinicians worldwide to process thousands of neuro exams each year…”
Mcap 5m!
Usual caveats
Trek
Sign In
Follow the stocks
