Replies to post #225450 on Innovation Pharmaceuticals Inc (IPIX)

[Amatuer17]

Well said - “For the shareholders, far more important than being upbeat is being vigilant, objective, and patient. You don't need rah-rah and grandiose claims, you need results”

Been burned by the upbeat CEOs of ARTH-AVXL-CYDY and obviously this one

[F1ash]

I should note also that if a CRO is used, management is as in the dark about blinded results as shareholders, unless they get a planned contractual interim report. This is probably a surprise to most retail speculators. They are not advantaged.)

This seems like the most important item to understand correctly if one seeks to interpret company actions/inactions appropriately imho.

I assume you are speaking from personal experience so I’m not disagreeing with how you state the system operates. I have tried multiple times to find a definitive answer to whether or not management can see the blinded data. Below is the closest to an answer that I have found.



https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.52

“Sec. 312.52 Transfer of obligations to a contract research organization.

(a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization.

(Bolding mine)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.56

“a) The sponsor shall monitor the progress of all clinical investigations being conducted under its IND.
(b) A sponsor who discovers that an investigator is not complying with the signed agreement (Form FDA-1572), the general investigational plan, or the requirements of this part or other applicable parts shall promptly either secure compliance or discontinue shipments of the investigational new drug to the investigator and end the investigator's participation in the investigation. If the investigator's participation in the investigation is ended, the sponsor shall require that the investigator dispose of or return the investigational drug in accordance with the requirements of 312.59 and shall notify FDA.
(c) The sponsor shall review and evaluate the evidence relating to the safety and effectiveness of the drug as it is obtained from the investigator. The sponsors shall make such reports to FDA regarding information relevant to the safety of the drug as are required under 312.32. The sponsor shall make annual reports on the progress of the investigation in accordance with 312.33.”


Outside of those links I also seem to remember that a DSMB was designated for the Prurisol trial. Could they be people from IPIX who are seeing the results?


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312

[CanesNH]

Short term there has been pain in seeing the sp decline and cautious optimism in seeing the trials show promising results. I know nothing is a lock but using previous results pre-clinical and clinical can lead one to deduce our chances of a successful indication for one if not multiple drugs is good. It will definitely hurt if P results are not good but B will likely rise us from the ashes. The combined anti-inflammory anti-infectious properties of this drug are ideal for treating so many disease conditions and screaming for a BP to step in and explore.

[DaubersUP]

Your right about the rah-rah. No need. We go off results. So far they are good to excellent. Waiting on number 8 to keep that .1000 batting avg.