help(2), page-18

Here are a few of my thoughts and comments are eagerly invited:

1. Ppeter, apart from the justifications you suggested, we should emphasize the fact that Vitrogro has outstanding clinical test results achieved by significant medical experts here and overseas. TIS has also received safety and manufacturing audit approvals in some form. TIS is not trying to Prematurely jump the queue as TIS has the credentials. TIS is being held up in distant country not because of any shortcoming but by technicality designed to frustrate and destroy new competitions.

2. Someone previously mentioned here somewhere that the equivalent of FDA in Australia meets only once every quarter. This is clearly not serving the Australian people but to the advantage of the big pharma’s. Instead of tackling BIS in hostile Europe, we might want to tackle our own review board in AUS because we have more friends than enemies here. The Health Minister should be taken to task over the infrequent meetings. Can someone shoot him/her a “please explain” email? Alternatively can someone get Tony Abbott’s shadow Health Minister to ask a parliamentary question? If we can force an emergency review of Vitrogro that will be helpful to our cause.

3. Having said the above, TIS has to agree to proceed with an AUS application in the first place. Fill in some forms. Change the covering letters. A few days work?

4. I know the Diabetes Australia organisation exists but there might be an “ulcer sufferers network or care group” in existent somewhere? In fact, TIS should know all its potential customers organisations. Please assist.

5. TDA, as far as I know, mass communication through the internet has to start somewhere and is usually easier in one’s own country before spreading worldwide without the constraints of country borders. The value of an AUS approval cannot be measured by the initial dollars. When a product goes “viral” the $$ can be 100x, 1000x or more and coming in record time.


6. When the European people hear that an Australia Approval has been given and the results are sooo outstanding, they will tackle the BIS, EMA themselves!? After all it’s their job and their own health concern.

7. Just noticed that a young AUS athlete named Michelle Jenneke whose Youtube went viral in July this year and had 16,000,000 views in a week (check wikipedia). Someone is leveraging on her success and posted a video called Forever Alone meets Michelle Jenneke only 3 days ago and has achieved 4 million views. Keep her and that sort of success in mind and think of the possibility for TIS........but you must get it right with some expert help.

8. Given that the decision to refer to EMA is totally inappropriate, is there any way to appeal? Are there any prior examples of successful appeals? The associated question is whether it will take longer and cost more to appeal.