Saturday, August 10, 2019 6:18:11 AM
I am sure that the medical and RA communities will understand. My concern is the investment community and its perception of "mixed" results. Long tail success may be counterbalanced by failure to meet the primary/secondary endpoints. Thus, share price may not move the needle. We have already seen this with the JTM. It reported rather good results but the share price needle was not sustainably moved. This was due to the facts that the results were blinded, were measured against historical norms from surgery and not randomisation and the primary end point, PFS, was not addressed on a blended basis. So you could say that the JTM results were "mixed" thus not moving the share price needle.
Same could easily happen with top line and the market's reaction thereto. Not only do results need to be stellar wrt to long tail but they need to be presented in such a way as to ignite the investment community's interest.
If not, fund raising at unattractive share price levels will drive the share price down. Mixed results as perceived by the market will not virtually guarantee FDA approvals expeditiously or otherwise. While there might ultimately be RA approvals including the FDA, the road to these approvals may be protracted and painful for long suffering investors---unless you are one of those investors in for the very long run and don't really care about interim share price damage. I also fear that absent stellar results, given the FDA's BP leanings, they may decide to issue a CRL. Not an outright rejection but a serious bump in the road with approvals in the more distant future.
I hope you are right though, although i think my fears are well founded. JMHO.
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