The bad news is that my call was return when I was on the way to the hospital for a family member. Everything to that end seems ok although more testing may be needed tomorrow. It did however have an impact on my notes which where all kept in my tiny little brain. Sorry for the lack of details. Nothing here is verbatim from Roy
Did the 10mg dosage come about as a results of safety concerns by the FDA or any unexpected safety problems in the PK trial.
No. The FDA had no roll in this decision. It was made internally to see if this would be an effective dose. We feel we can we can possibly reformulate this dosage in the future. (i was in a hurry so I did not pursue this subject)
So no new health concerns showed up in the PK studies or health concerns in regards to past animal studies that had any thing to do with this decision.
No. The fda had no new major concerns, concerns beyond what would be expected of any drug. They have seen the cancer data at much higher dosages.
So no thrombosis etc... No
Why the sudden change from improved vision to maintained vision in the recent rodman webcast.
We decided to back off that. With our delivery method we can still get the market with results similiar to the competition. If we continue to show improved vision at higher dosages when we get that data, that would be great.
Why can't we be told where squalamine is made. IMCL for example had no problems telling us about Lonza making erbitux.
For competitive reasons we are choosing not to disclose this data. If I told you you would then be an insider. It would be easy to figure out where erbitux is made because of the type of drug it is. He gave me more detail here about parts of the drug being made one place and then shipped somewhere else for more processing. I was busy weaving in and out of traffic at the time.
So lack of Drug is not the reason it took so long to start the phase II trial when the 10mg dosage was added. -
No not at all (very defensive). We feel the delay was not excessive. He gave me more detail here, I just can't remember it. He did cover alot of things they had to do.
He knew I was on the way to the hospital. He was nice and answered all my questions. I am sure others here will continue to have concerns regarding safety issue of squalamine. I understand that each investor must make up there own mind and be reponsible for their own loses or gains.
As for me, I'am not concerned over the safety issue of squalamine. I still feel the start of the phase II trial was excessive but it is going and enrollment is proceeding so unless new information comes about this is not reason enough for me to sell. He sounded very confident that there would be no problem getting squalamine. It could be made by a lot of companies.