I am disappointed (I’m sure Brady is as well) that we have to wait until Jan 2018 for the pre-ind meeting. I’m aware of all the federal grant funds that were awarded to the states. I’m not so sure how the states will appropriate those funds...if any to industry/when.
Next, we WILL have to go through trials, most of the ongoing concerns for Naltrexone implant is the lack of data to support how one will do. I doubt we will be able to skip trials, but hopefully we can skip a lot of the requirements and go straight into a Phase 3 study, to just get this implant of Naltrexone approved. So I expect a study that is hopefully funded by either the grants or NIH, which will evaluate the safety and efficacy for long term extended release (6 months or so) of Naltrexone.
This approach isn’t new, since Braeburn and Titan has to go through the same thing with Proburphine. I just hope we don’t RS (the way Titan did to get on NASDAQ before they got their implant approved). I hope we get some form of funding from somewhere to keep lights on like TEB mentioned sometime ago.
At the moment, Alkemeres has a ton of cash on hand so they could very well, possibly buy us out. Unfortunately, we don’t lose a threat to their current primarily revenue source (Vivitrol). We need to cut into their profit margins for that to become a reality. There’s too much uncertainty for me to accurately make an estimated SP for upcoming months. I do believe if FDA grants fast track or some form of an expedited review, and we use grant funding from somewhere to pay for those trials. We’ll be in a good position.
With regards to an IND application cost, I believe someone will jump in to cover those costs otherwise we will have to issue more shares to keep moving forward.
I hope in 6-8 months we will be trading @ 0.5
