Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Sorry, LR, been busy day and I am late with this reply.

I stand corrected. I should have written 'no evidence of BTD'.

I have doubts how complaint of omission to point out otherwise obvious fact would fare in legal actions. Reporting SOM incidence rates for intent to treat population plus only one out of possible two subgroups is like saying:" 5 minus 3 equals..." And leaving it to readers to figure out that it is 2 that follows. Seems to to OK as long as there is means for the reader to figure out what it was highlighted.

One enlightening example:
Yondelis was approved on 2016 to treat leiomyo- and liposarcomas (two most common soft tissue sarcomas, STS) based on statistically significant benefit in progression free survival (PFS). You can't find this tidbit in Yondelis FDA label or in the discussion section of published, peer reviewed article about the pivotal phase III clinical trial (comparator dacarbazine is generally considered borderline active in STS i.e. just above placebo):

Progression free survival in Liposarcoma overall Yondelis (trabectedin) vs dacarbazine
Yondelis: 3.0 months
Dacarbazine: 1.5 months

Progression free survival in Liposarcoma subgroups Yondelis (trabectedin) vs dacarbazine
Dedifferentiated
Yondelis: 2.2 months
Dacarbazine: 1.9 months

Myxoid / round cell
Yondelis: 5.6 months
Dacarbazine: 1.5 months

Pleomorphic
Yondelis: 1.5 months
Dacarbazine: 1.4 months

What do we see: Benefits Yondelis shows in liposarcoma are completely driven by Yondelis performance in ONE liposarcoma subgroup. This is not mentioned (no limiting clause for liposarcoma) in Yondelis FDA label and not in the discussion for Yodelis efficacy in the published, peer reviewed article about Yondelis phase III trial. So, how do I know about it: the above is from a table in Fig 2B of the trial article. That's it.
links:
Yondelis FDA label (the latest):
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s005lbl.pdf
Yondelis pivotal Phase III trial:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070559/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5783302/

I could provide several other examples, but what would be point...