Hi, guys -
Got back from ASM too late last night to post. And UM-tiger did a very good job of posting one of the conversations with SK that I heard .
Attendance was lighter this year than in past years. It was fun to see a lot of familiar faces, though.
Anyway, here's a few of the Q & A comments. Not 100% inclusive of all of the questions, 'cause I couldn't write fast enough to get them all...All questions and answers are paraphrased from my notes to the best of my ability...
Andy - When the trial sites open, do they already have patients to treat?
Sk - They start screening after the site opens.
Andy - Are any of our collaborations in the viral area?
SK - Yes, we have some in viral.
Safrong - Do we do anything to let patients know about our trial?
SK - Given the number of sites, the patients are there. We just need to make sure that they get into our trial.
Joe - We do have a program of company employees that go out to the sites to meet with the doctors and tell them how excited we are about our trial.
(see UM-tiger's post about Steve and Joe going to as many sites as they can.)
Bob - If data warrants it, would we apply for breakthrough designation?
SK - If it helps speed things up, yes.
Rob -It depends on the data. If data p value is 10 to the minus 9, there won't be an ODAC meeting. If the p value is .048, that guarantees an ODAC meeting. Breakthrough designation is for companies with stunning data. Because of phII, we're not there yet, but if phIII warrants it, yes, we'll go for it.
Brandon - Can you comment on ebola?
SK - Ebola should be studied, and we are pursuing that. The government should be leading the way. There are only about 4 or 5 places in the US where ebola can be studied, and the government has them all. We want to be involved.
Brandon - When we lost the DTRA contract, my understanding is that it was because there was not a single dose that was consistently effective? Is this only true in ebola?
SK - Part of the problem was that viral moves so fast. Based on our current knowledge of the mechanism of action we can apply it differently now.
Safrong - Is there any update on the imaging trial?
SK -It is progressing very nicely. Part of the problem is that cancer patients don't want to be in and imaging trial when they can be being treated for cancer, but it is moving along nicely lately.
Brandon - Are IL2 and interferon possible combinations for ebola?
SK - Yes, along with several others.
Bob - How long before we hear about betabodies?
SK - It's in the preclinical pipeline - not a big focal point, but moving.
Andy - Is there a problem with the betabodies patent?
Shelly - No problem. Remember, the first action is usually rejection, which caused a slight delay in the US. In the EU we have been hopeful that if we wait a bit, we will be able take advantage of pending legislation to save several hundred thousand dollars. (in a side conversation, she explained that currently, to get European patents, you have to get approval in each individual country, which can cost half a million dollars, but there is legislation (already approved, they're just ironing out the details of where the head offices will be) that will allow you to file once for approval in all EU countries. That could save us upwards of $400,000, so they are waiting for a couple of months).
Vicky - Can the EU approve Bavi independent of the FDA?
SK - Yes, they are independent processes, we will file in both places.
Randy - How do you connect a KOL to the drug approval process?
SK - Drug approval is a government process, and the government doesn't have experts in every field. KOL's could go to the ODAC meeting. KOL's help in overall general acceptance of a drug.
Rob - KOL's help recruit patients to trials. KOL's and patient advocates will be at the ODAC meeting. But where KOL's really help is after the drug has been approved, and is on the market, by getting doctors to use your drug.
Bob - Will we get a PR when half of the patients are enrolled in Sunrise?
SK - I don't think so. (Later Chris K. said that we would definitely get a PR for total enrollment.)
Andy - Any progress on Dr. Stopeck's paper?
SK - The process is extremely variable. It takes a long time to complete the review process.
Safrong - If the government is working with Bavi and ebola, and they want to buy a bunch of Bavi, can we supply it?
Sk - Yeah, it's available. We're waiting by the phones. (Said tongue in cheek)
Brandon - Are we building out Avid?
SK - We believe Sunrise is going to be successful, so we will need to be able to meet that need, and also, Avid has a growing customer base.
Unknown - Do we have any potential partnerships?
Steve Worsley - Yes, we are in active discussions.
One other comment in regard to the post that Um-tiger made about early look-ins. My understanding is that the first early look-in is to look for adverse events and signs of efficacy. If there are too many adverse events, or no signs of efficacy, the trial will be stopped, but early approval is not a possibility at first look-in. Second look-in is when we have a chance at early approval. SK indicated that we are about where they expected to be in terms of patient enrollment (not ahead, not behind, but on track for full enrollment by the end of 2015) and they are expecting (guessing) that that is about when we will have enough events (deaths) to get the second look-in.
