JOURNEY to 50c plus, page-278

Anxiousness and negativity on this forum. End is near or maybe this has bottomed. If I knew, I wouldn't be here.

We are all focused on phase 1 trial results, the company says it doesn't have conclusive results but it may have enough from 5 patients to get a commercial partner involved to help speed up things or go to US/Europe/Asia for expanded trial.
Safety is the primary end point of the study which is fine until now. NP are reaching lymph nodes which is great. We know Iron Nano particles react to magnetic pulse. The HER 2+ antibody used is widely used and works. At some point, they will have 10 -15 patients that they need to provide conclusive data. Until then, it is all speculation and quarterly cash burn. near term upside will be the R&D tax rebate which was ~2Mil last year.

Here is a refresher on Outcomes:

Outcomes

Primary outcome [1]

Incidence and severity of adverse events via clinical examination and classifed by CTCAE v5.0 criteria

Timepoint [1]

Days 1, 2, 3, 4, 7 and 28

Primary outcome [2]

Incidence of serious adverse events via clinical examination & review of medical records and classified by CTCAE v5.0 criteria

Timepoint [2]

Days 1, 2, 3, 4, 7 and 28

Primary outcome [3]

Clinically significant changes from baseline measured by haematology (blood sample) and chemistry parameters (blood and urine samples).

Timepoint [3]

Screening and on days 1, 2 and 4.

Secondary outcome [1]

Lymph node detection rate of the test reagent assessed by iron and HER2 histological staining of the lymph node biopsy samples (colocalisation).

Timepoint [1]

Day 4

Secondary outcome [2]

Lymph node detection rate assessed by MRI scan of the upper body (lymph nodes).

Timepoint [2]

On Days 2 and 4.

Secondary outcome [3]

Lymph node detection rate assessed by MRX imaging of the lymph node biopsy samples.

Timepoint [3]

Day 4

Secondary outcome [4]

Lymph node detection rate identified by MRX imaging of the lymph nodes compared with MRI imaging and the histological findings of the lymph nodes (Iron staining and HER2 status).

Timepoint [4]

Day 4

Secondary outcome [5]

Incidence of injection site reactions by clinical examination and classified by CTCAE v5.0 criteria (additional primary outcome).

Timepoint [5]

At Days 1, 2, 3, 4, 7 and 28 days post test reagent administration