Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

More likely reason for denying BTD was performance in cisplatin weekly group which one can calculate using differences between all and cisplatin Q3W group. One can hardly be claimed to be a breakthru if performance in about half of the subjects is unclear (putting it politely).

SOM in subjects with cisplatin Q1W schedule in IPIX trial.
Brilacidin: 7 / 13 or 53.8 %
Placebo: 5 / 11 or 45.5 %
Note: surprisingly low SOM rate for placebo.

Dusquetide had similar (well, worse) failing in weekly cisplatin --> no BTD, applied for or approved.
Dusquetide: 9 / 12 or 75 %
Placebo: 10 /16 or 62.5 %
Note: in Dusquetide's trial placebo SOM rate was what one would expect.

Galera got BTD for GC4419 based on efficacy also in cisplatin Q1W group:
GC4419: 22 / 46 or 47.8 %
placebo: 31 / 46 or 64.9 %
Again: placebo SOM rate was what one would expect - and treatment percentage not so far from brilacidin's.

An interesting observation:
cisplatin weekly group as percentage of ITT in three trials we have data from:
Placebo:
GC4419 - 46 / 76 or 60.5 %
Dusquetide - 16 / 38 or 42.1 %
Brilacidin - 11 / 25 or 44.0 %
Treatment:
GC4419 - 46 / 76 or 60.1 %
Dusquetide - 12 / 36 or 33.3 %
Brilacidin - 13 / 21 or 61.9 %

Interesting percentages. Galera probably randomized based on cisplatin schedule - judging from very close percentages between arms. Others did not.