Message from the other board from yooper61 who att
Post# of 72440
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Posted On: 09/20/2019 8:24:23 PM
Message from the other board from yooper61 who attended the shareholder mtg.
Yooper61 Friday, 09/20/19 02:27:11 PM
Re: None 0
Post # of 273126
I attended the meeting. They took questions for about an hour.
Question was asked why there is even a need for a B-OM P3?
The FDA needs to verify safety. Mgt said that B was embraced by the FDA. The fact the FDA has approved moving forward with P3, with such a modest sample size is impressive. The FDA is fine with the primary endpoint being high dose every 3 weeks. The trial size requested is 300 active drug recipients. They would go 2:1 drug:placebo, so 450 trial size. They said that the FDA even offered suggestions for improved labeling. However, the Break Through Status fell through due the results of the weekly cisplatin. The EMA wants the whole population. They said they will look at both groups and are “harmonizing” the requests.
They said BP is not interested in cancer support, so it is mid to small companies that are in the data room now, and that they are in talks with them about licensing deals. The AS upfront will be disclosed in the Q. It has not been yet, so as to not show all your cards the B-OM negotiation. So…I believe it will be very small. The main purpose of that deal was validation and the data that they will receive to support B’s effectiveness in the larger indication of IBD.
I asked what was AS’s expected development timeline? They said summer is a down time in Europe, and that Joint Development Committee will be meeting and they should know more in about a month. They noted that in the B-UP trial, they dosed via a crude enema, and that AS would be developing a commercial drug, testing safety and then a controlled trial. AS has to develop in earnest or they can claw back the asset.
The B-IBD pill trial will start in December (wiggle room) and go quickly. I asked if the next step would be another proof of concept trial like B-UP? My thinking was that we licensed B-UP from an 18 patient, open label trial, so repeat that with B-IBD. They said, that BP wants to see a 2a. BP told them that if they can show them a successful 2a, they will be “knocking their door down.“
The first term sheet fell through due to a change in management. The new mgt wanted to focus on their existing business and did not want to go off in any new directions.
I asked why they renewed the lease and what are their plans for it? They said they intended to use it for a P3. They saved millions in the P 2a doing work in-house vs. paying a CRO. They have engaged a realtor to sublet all or part of it.
I asked why the Ireland office? They said they need it for future dealing with the EU for approval of drugs. If they are going do trials in Europe, they need an EU office. Also, having an EU office saved them a significant amount of money (90%) in scientific consulting. I didn’t understand this, but I didn’t get the opportunity to ask clarifying questions.
Why was the SH meeting in GR? Dr. B lives in Ann Arbor, and that they are using ex Pfizer exec’s that he has worked with in the past, as Tox consultants. Didn’t say which drug(s) they were consulting on. They did say they were half way through with the toxicology work on Kevitrin, but I think they said that a year ago too.
Leo said he doesn’t read the message boards. The FUDsters are still active on a 13 cent stock so they will never have to cover and pay taxes.
At the end, Leo said that he will provide more clarity in the coming weeks. “A new direction, a new understanding of what’s going on, actually growing the company, not shrinking it.” They may engage a P/R firm…long overdue!
Asked, what are the prospects for a B-OM deal? Leo said he couldn’t say, then Dr. B spoke up and said, “I’m still here after 3 years, and if I didn’t believe, I wouldn’t be here anymore.”
https://investorshub.advfn.com/boards/read_ms...=151266217
Yooper61 Friday, 09/20/19 02:27:11 PM
Re: None 0
Post # of 273126
I attended the meeting. They took questions for about an hour.
Question was asked why there is even a need for a B-OM P3?
The FDA needs to verify safety. Mgt said that B was embraced by the FDA. The fact the FDA has approved moving forward with P3, with such a modest sample size is impressive. The FDA is fine with the primary endpoint being high dose every 3 weeks. The trial size requested is 300 active drug recipients. They would go 2:1 drug:placebo, so 450 trial size. They said that the FDA even offered suggestions for improved labeling. However, the Break Through Status fell through due the results of the weekly cisplatin. The EMA wants the whole population. They said they will look at both groups and are “harmonizing” the requests.
They said BP is not interested in cancer support, so it is mid to small companies that are in the data room now, and that they are in talks with them about licensing deals. The AS upfront will be disclosed in the Q. It has not been yet, so as to not show all your cards the B-OM negotiation. So…I believe it will be very small. The main purpose of that deal was validation and the data that they will receive to support B’s effectiveness in the larger indication of IBD.
I asked what was AS’s expected development timeline? They said summer is a down time in Europe, and that Joint Development Committee will be meeting and they should know more in about a month. They noted that in the B-UP trial, they dosed via a crude enema, and that AS would be developing a commercial drug, testing safety and then a controlled trial. AS has to develop in earnest or they can claw back the asset.
The B-IBD pill trial will start in December (wiggle room) and go quickly. I asked if the next step would be another proof of concept trial like B-UP? My thinking was that we licensed B-UP from an 18 patient, open label trial, so repeat that with B-IBD. They said, that BP wants to see a 2a. BP told them that if they can show them a successful 2a, they will be “knocking their door down.“
The first term sheet fell through due to a change in management. The new mgt wanted to focus on their existing business and did not want to go off in any new directions.
I asked why they renewed the lease and what are their plans for it? They said they intended to use it for a P3. They saved millions in the P 2a doing work in-house vs. paying a CRO. They have engaged a realtor to sublet all or part of it.
I asked why the Ireland office? They said they need it for future dealing with the EU for approval of drugs. If they are going do trials in Europe, they need an EU office. Also, having an EU office saved them a significant amount of money (90%) in scientific consulting. I didn’t understand this, but I didn’t get the opportunity to ask clarifying questions.
Why was the SH meeting in GR? Dr. B lives in Ann Arbor, and that they are using ex Pfizer exec’s that he has worked with in the past, as Tox consultants. Didn’t say which drug(s) they were consulting on. They did say they were half way through with the toxicology work on Kevitrin, but I think they said that a year ago too.
Leo said he doesn’t read the message boards. The FUDsters are still active on a 13 cent stock so they will never have to cover and pay taxes.
At the end, Leo said that he will provide more clarity in the coming weeks. “A new direction, a new understanding of what’s going on, actually growing the company, not shrinking it.” They may engage a P/R firm…long overdue!
Asked, what are the prospects for a B-OM deal? Leo said he couldn’t say, then Dr. B spoke up and said, “I’m still here after 3 years, and if I didn’t believe, I wouldn’t be here anymore.”
https://investorshub.advfn.com/boards/read_ms...=151266217
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