New to this board, but been contributor for quite a while on YMB.
It is a zoo there and the new bot rejects valid threads for no good reason.
I have a current holding of 15k, but my primary holding is SAVA.
I have been a long time participant in the SI IMMU board, where many of us have been following the SAVA/AVXL clinical progress and shorting saga.
I had been asking what exactly is the phase2b/3 trial just completed???
It is commonplace that upon completion of an FDA phase 3, that an NDA is forthcoming soon after,
but I don't hear that from the CEO.
look up Avanex2-73 on clinical trials.gov
go to the very bottom of the document and find:
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
now I went to clinicaltrials.gov FAQ and found the following:
" Therefore, a study record that (1) does not list "United States" (or a U.S. territory) for the Facility Information/Country data element, (2) lists "No" for the U.S. Food and Drug Administration IND or IDE data element, and (3) lists "No" for the Product Manufactured in and Exported from the U.S. data element, would indicate that a studied device product is not "subject to" section 510(k), 515, or 520(m) of the FD&C Act. For such a study, the responsible party would list "No" for the Studies a U.S. FDA-regulated Device Product data element and the study would not be considered an applicable device clinical trial. Note that even if the device product being studied had previously been approved or cleared by the U.S. FDA under section 510(k), 515, or 520(m) of the FD&C Act for marketing in the U.S., that responsible party would list "No" for the Studies a U.S. FDA-regulated Device Product data element because the particular device product used in that study is not subject to those sections of the FD&C Act.
The Final Rule preamble also addresses whether a studied product meeting the drug definition is "subject to" section 505 of the FD&C Act or section 351 of the PHS Act. The Final Rule preamble states: "[A] clinical investigation of a drug product (including a biological product) that is being conducted entirely outside of the United States (i.e., does not have any sites in the United States or in any U.S. territory) may not be a clinical investigation of a drug product or biological product subject to section 505 of the FD&C Act or section 351 of the PHS Act, and therefore not an applicable drug clinical trial, depending on where the drug product (including biological product) being used in the clinical investigation is manufactured. … If the drug product (including a biological product) is manufactured outside of the United States or its territories, the clinical investigation sites are all outside of the United States, and the clinical investigation is not being conducted under an IND, the drug product or biological product would not be considered to be subject to section 505 of the FD&C Act or section 351 of the PHS Act, and the clinical investigation would not be an applicable drug clinical trial." (81 FR 65015) "
So my original conclusion that Avanex has a lot of negotiating with US FDA to accept the completed trial as is and/or the possibility of an entirely new phase 3 is a real possibility.
That said, it is entirely possible they could file for approval in Australia or elsewhere, but transparency from the CEO is severely lacking, AND they need to complete the full data analysis first.
I do feel that the topline data they did present, was lacking in taking credit for some % of super responders which were hidden in one or more of the numbers they did display. If so, they can claim to be the second drug after simufilam that actually improved cognition in mild AD at one year, and puts them a head above Biogen and Lilly.
This board would probably appreciate if someone knowledgeable would play devil's advocate and explain what I may have missed in the above.
Bullish
