Replies to post #80288 on Rivulet Media Inc (fka RIVU)

[sup105]

Yes its not a big market that is for sure

For Dr. and pharma companies more sicker people there is more money they earn for now.

Which they will change that system in future, but seems to me it won't happen anytime soon.

However I do think that BMSN is trying to sell a technology not a product, Since their research approach is highly relate to leukemia.

Also for Breast cancer in north America its 92 out of 100 000 "Newly found every year" In health profession we were to identify every 1.5 out of 10 Caucasian female will have breast cancer sometimes in their life time. Not to mention those number will exponentially increasing due to late pregnancy.

http://www.cdc.gov/cancer/breast/statistics/race.htm

seems to me still 1/3 people die from breast cancer Soon it will become "huge deal" in near future.

[Sooah]

Good morning,

I believe many folks are misunderstanding my comments, however you have the right understanding of my concerns/comments.

First of all, no one said there could not be a clinical trial with 10 people or less. There have been Phase 1 trials for aplastic anemia (AA) or severe acquired aplastic anemia (SAA) involving 8 patients to 30 patients, some even greater number like 108. For example, Neupogen was studied as a combination therapy involving 18 patients in Phase 1. Note that this was a double-blinded comparison study with healthy volunteers randomized to one of 3 treatment groups. The required study size is really not fixed but depends on what is being studied, study allocation, data sets and so on. As it relates to Regen, the public has not been provided enough data to make an informed decision about what they are doing with these 10 AA patients. They've hinted with the market size in billions of dollar but does anyone really know anything of significance? I have not seen any raw data and doubt any one on the retail side has.

What we do know about the majority of AA studies is that their primary endpoint is Response and secondary Survival. Patients are followed up on a 3 month interval basis if short but normally 6 months is used to measure Response. Survival is measured in months/years. Due to the severity of this disease, many of the study subjects--as you have pointed out--do not live long enough to complete a study. Note that some Phase 2 studies have taken 4 years for data collection.

Also, those with AA are already on some sort of therapy (or combination therapy) using ATG and cyclosporine if they were not able to find a donor match for bone marrow transplant. This is standard care. Time is of the essence here so any biotech looking to do a new study will be hard pressed to find patients that are willing to be subjects of a new study if they're already receiving treatment that is helping them. Patients are lucky if they made it beyond late P1/P2 and this is their/your reality. The "numbers" and the disease itself simply work against regulatory approval whether you're willing to accept it or not. Because of this, it becomes very challenging for most researchers to prove their treatment works, simply because the treatment must show Response at 6 months, a reasonable survival rate or overall survival. This requires patients to be alive...

For these and many other reasons which I may comment on a later time, it only helps if the study size is bigger than 10. You don't want 6 out of 10 with positive response to be gone during P1, do you? What does that leave? 4 out of 10?

Something to think about for those who still can think independently.

Best luck to all regardless,