Friday, September 30, 2016 10:52:47 AM
If no advantageous offer from any big pharms on collaboration with D and/or L such as significant upfront payments, etc, let it be, and do wait for the completion of L.
The quietness of over more than a year regarding L should continue if the company has not obtained any fruitful resolution on numerous and various suspected and reasonably understandable fronts:
1) Seek approval of L according to original and/or modified protocols, meaning, demonstrating ss > 4 months of PFS difference plus some OS benefit, either ss or not;
2) Seek approval of L according to original and/or modified protocols, meaning demonstrating that L indeed provides OS benefit even if it misses its primary PFS target (I don't see why FDA would not approve L if, for instance, the company may have enrolled about 330 patients around Oct last year, and the trial can demonstrate median OS 18 months of the control arm versus 28 months of the treatment arm. But if the trial can demonstrate ss 22 versus 24, that may be tough if the trial miss its primary target);
3) If the company can establish a reasonably solid correlation between identification of a subtype and clinical benefits, although it may not be included in the original protocol, if that relation can be reasonably established, I don't think FDA would have any hard time to approve L for that specific population;
4), 5), ...
I believe the above process is on going alone or concurrently. It's a long wait, but it is definitely approaching a resolution if not today and yes you bet tomorrow.
Shorts have been covering but still in denials thinking they will have enough time and can time the market (or simply they just cannot cover their huge naked short shares without wakening the general market which will in turn bury them significantly underwater) while the general market has not yet had a serious look at this company for so long.
When thing changes, it will be a tsunami.
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