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Message: Insiders info

This is a crazy thought, particularly given ledenfrogs explanation for the stock price dive, but, I wonder if the insiders feel that the probability of a phase lll BETonMACE trial approval by the FDA is extremely low????

I still feel there must be a chance for the following reasons;

  • Don, Dr Wong and Dr Johannson all started speaking about this trial in February with a great degree of confidence and certainty. They were very public and confident in front of their peers.
  • EU approval for BETonMACE phase lll has been achieved.
  • In masila's summary of June 30th Don said they are in active discussions with the FDA and working out their strategy.
  • Hepalink would not have bought in without a strong belief of approval so at least China will go ahead but I'm sure they (Hepalink) would have expected FDA approval as well. Remember, Hepalink owns companies in the USA and they could become a take it to market company for the USA for rvx-208 although that is not the current situation.
  • They continue to present peer reviewed research.
  • They continue to learn more about the MOA of rvx-208 and these discoveries are very exciting indeed and would be of value in discussions with the FDA and as well as BP such as AZ.
  • The quality of medical and scientific knowledge and credentials on the BETonMACE phase lll trial's steering committee is exceptional to say the least. They would not spend their time unless they felt that all of the previous research by RVX did not have sound scientific integrity and high potential.
  • We all know that the knowledge from post hoc findings must be replicated. However, when the MOA begins to be discovered (as is the case with rvx-208 and it is all positive as well as profound) then even data from small samples yields validation to the impact of rvx-208. e.g. think about photosynthesis or the oxygen cycle or the process of ADP to ATP. These are well understood cycles. rvx-208 is on the way to beginning to be understood in terms of it's MOA.
  • The diseases that rvx-208 could impact, and there are many, are costing the American health care system billions. RVX has the post hocs on rvx-208 relative risk reduction at 55% for total sample and 77% for DM, CVD and low HDL and these results are highly statistically significant.
  • rvx-208 has proven in at least 2 trials that it increases ApoA-l (functional HDL) at highly statistically significant levels.
  • rvx-208 has a very strong safety profile.

So my guess is that they are making progress with the FDA and there is still a chance for phase lll.

GLTA

Cheers

Toinv

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