The darkest hour is just before the dawn.
Call me crazy, but my gut feeling tells me that we will get significant positive news within the next 4 weeks.
Here are possible catalysts:
1. Meeting and (commercial) agreement with Purdue (case status conference scheduled for December 17, 2018)
Remember: "As a result of the commencement of the first of these legal proceedings, the FDA is stayed for 30 months from granting final approval to our Oxycodone ER product candidate. That time period commenced on February 24, 2017, when the Purdue litigation plaintiffs received notice of our certification concerning the patents, and will expire on August 24, 2019, unless the stay is earlier terminated by a final declaration of the courts that the patents are invalid, or are not infringed, or the matter is otherwise settled among the parties."
2. Update on the results of the abuse liability studies
"The abuse liability studies for the intranasal route of abuse commenced in May 2018 with subject screening, while the studies to support abuse-deterrent label claims for the oral route of abuse commenced in June 2018. The clinical part of both studies has now been completed. Bioanalytical samples and statistical analysis for such studies are pending. An update on the results will be provided once the analysis is complete."
3. Submission NDA for Oxycodone ER
"The FDA granted our request for an extension to February 28, 2019 to resubmit our NDA for Oxycodone ER under section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. However, we plan to resubmit the application later this year."
My personal opinion:
Odidi has - at least according to my perception - diluted as little as possible for a very long time. Only the fatal AdCom meeting led to an emergency situation that he didn't expect. The last financing was an "all-round blow". In my opinion, it was the last time he secured capital to finance the court proceedings and the studies for the new NDA and to maintain the Nasdaq listing. Odidi knows very well that he is running out of time. He therefore brought the IND with PODRAS - as a threat to Purdue.
IF the studies have gone well and IPCI can submit the NDA, it is Purdue's turn, because as stated above, marketing can theoretically start from 24.08.2019. And IF PODRAS is as good as Odidi believes, every drug with this technology would almost automatically be superior to the others. If Oxycodone ER succeeds in gaining approval, IPCI would have sufficient financial means to advance it. I suspect, however, that there will be a deal with Purdue before that.
In any case, the Nasdaq deadline on January 10 puts massive pressure on Odidi to agree to a deal. Without a Nasdaq listing, he will never be able to make millions in financing again. That would be the end of his story.
cysonic
