I spoke with Chau last Friday. The following is an abbreviated version of what we spoke about.
1)The first thing I noticed is just Chau's attitude. He sounded absolutely ebullient about the company's current course. He reiterated multiple times that there is "laser focus" on 132 in TNBC, and that morale is high thoughout the company. He also mentioned that in several months, he's excited to be able to go home and tell his kids that his company is making a drug that will help women with TNBC. He wanted to pass along that there is a new consistency and transparency to the company under the new board.
2)In terms of a new CEO, they have now hired an executive search firm. He is unsure if any interviews have taken place. In any case, it didn't sound as if an announcement was imminent.
3)He admitted that the current website is obsolete, and he hopes to modernize it, but that probably won't be ok'd until a new CEO is appointed.
4)Any licensing deals, or deals for combination therapy with other agents, will apparently wait for a new CEO. Similarly, no decisions will be made on clinical trials on such compounds as IMMU-140 and (E3)-1s until the CEO is hired. Pre-clinical studies will continue unchanged.
5)The FDA has greenlit the drug to be used for the 132 P3. What the company is working on now is manufacturing for when it's approved. They have enough for the first 12-18 months, but there is a manufacturer who can't get drug made from 18-24 months due to other orders, so they're looking for someone to replace that manufacturer. They will then need validation from the FDA for that. The FDA meeting will be happening soon to find out if a "rolling submission" for approval is allowed, though he couldn't give me an exact date. Regardless of the FDA decision, there will not be a PR, but there will likely be a mention in the conference call after the decision is made. |
