Replies to post #190186 on Avid Bioservices Inc (CDMO)

[Protector]

hutschi, NO! You start all your searches with knowledge that a patient does not have!

- You don't know about SUNRISE if you get diagnosed
- You don't know about CT with Bavituximab if you get diagnosed
- You don't even know the abbreviation NSCLC because doctors will tell you the disease name in full in your language (3rd time: They don't speak English in Russian submarines!).
- Let alone that you would know the treatment centres and be able to go search on a specific web-site. (Some are not even hospitals).
- And in 2/3 of the cases of this clinical trial the patient doesn't speak English
- last but not least, those patients don't have our know-how about the existence of clinicaltrials.gov, UTSW, etc, etc. Just ask some random person and you'll find out very quickly, certainly outside the US.


So the patient COMPLETELY depends on the Doctor. So now lets make my point a little more in depth because I sometimes think there are a number of people that have a hard time to understand what I am trying to say (probably my writing):

What DOCTORS are going to forward a patient with NSCLC to the SUNRISE clinical trial? Well in each treatment centre at least ONE if we assume NO influencing of the doctors.

But if I contact the Dana-Farber Cancer Institute I will never be told to take SUNRISE. They will channel me to SOC first and if they see I show some interest for one of the clinical trial they run I'll end up in another but SUNRISE NSCLC. The patient, given the lack of above listed search terms, will hardly find SUNRISE and if he finds it he will, as demonstrated, get wrong or missing information.

So, what has been achieved now:

- All those that want to find the treatment centres for the reasons that PPHM din't want them to find it, find them anyway because there is a certain determination if you want to find them if you have an agenda.

- The patients that research there disease have a hard time to find SUNRISE and locations of sunrise but fall on PLENTY of competing clinical trials. These will often be immunotherapy trials of which they'll find much more positive literature then on Bavituximabs who's name doesn't show up in the picture. (It was even reported here that the name Bavituximab was carefully removed from wiki pages, so you ill not find it as a treatment or search term).

- The number of doctors that can forward people to the clinical trials are limited and there is a high dependency on them to fill the trial.

- The number of Doctors being limited makes the trial vulnerable because a small group is easy to incentive wise have patients either turned away from SUNRISE or enter SUNRISE if they are extremely sick (see pancreatic cancer randomizing that is certainly not statistically significant!).

And again, there is NO problem with current enrolling, PPHM is on track, better then on track, but there is a reason for that and that has to do with the trial start-up, the recent contact with training of the people of the centres, and mostly the immediate availability with Doctors of patients which they might almost have given up and hence possibly see the CT as a last chance. But if we are done tapping out of that barrel we'll need more patients the next 6 months. And you do not always want to end up with those late stage IV patients.

So opening the field to EVERYONE solves all that because it increases demand. And that starts with:

- correct information in clinicaltrials.gov because it is the source from where everything proliferates.

- complete location information in clinicaltrials.gov so that patients don't start to call plenty of hospitals and get skimmed away into another clinical trials of the competition.

- possibly add some indication that when you call Jennifer Lay there may be some language support. It must not be to difficult in a company like PPHM to call in the support of someone that speak a language of the participating countries. That make a BIG difference and if you doubt about that just inverse the rolls and think of clinical trial.gov to be in China and you have to call Mr. Kim San Yo in Bejin and English is NOT the international language that it is (because that is how it is for people from Spain, Russia, Romania, etc) who are going to have to make an international call. So you either think you Chinese is either good enough or you probably don't make the call. You can of course ask someone else to call, which again for some countries is not evident, but then you'll have to talk about your cancer and many don't want that in the early stage.

PS: There are even automated systems that detect an incoming international call for the specific phone number of JL and you could have an automated menu with language selection of the CT countries and then followed with a short explanation before connecting to a person.That costs less then 20% of SK salary to install.