Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Bertolino or Harness would have understood the amount of work required from the get go. Also, all questionnaires have been in ClinicalTrials.gov filings since Oct. 2016. They were not a mid-trial change in protocol. BUT ...

You may not remember that this was discussed before: prurisol 2b trial enrollment got very back heavy. Original primary end date for the trial was June 2017, but enrollment reached only 70 % by mid-May 2017.

Heavy backend enrollment also meant delays on gathering and processing trial data. I would not be surprised if IPIX started to put pressure on CRO by Q3 2017. That may have backfired and created a mess --> CRO adds workforce on prurisol trial --> additional workforce may have been inexperienced with the type of trial --> something got omitted or mishandled --> reset data processing.

Of course this is just my opinion, but it is based on reading about problems associated with CRO:s. Most complaints are about what happens when CRO:s do reduce cost by
1. Assigning less educated plus less experienced and hence a lot cheaper persons to do tasks they are not yet qualified.
2. Compressing time allotted to process and verify data.

Disasters happen with the above recipe. BTW, big money pharma tends to keep crucial trials in house and hand "Mee-Too" stuff to CRO's. You should be now able to guess why.

If I am correct it does not necessarily follow that CRO just re-processes the data and delivers it badly late but in good condition. It all depends on at which stage of data collection the errors were made - there may or may not be a permanent data loss.

Remember to bless FDA in your evening prayers. If my memory serves me, FDA still requires that all site trial data is preserved (locally) for some years after the trial - there is hope.