RE:Had a contact with IR Good post Oilminer - and best wishes for the Gym.
Definitive results on enduring CRs in at least 25 may not be received until late 2021 or beyond but wouldn`t write off the possibility of the Company issuing selective data much, much earlier.
The wording of ShuShu`s reply to Investclub was interesting:
‘Shushu said the Company wanted to stay within the guidelines of other PH2 trials and only release results of significance such as 25 patients needed for fast track…’
Note that these are the guidelines of other Phase II Trials and not (yet) the guidelines of this one. This leaves - as I suggested earlier - the option of that 3-month release but the Company is sensibly refraining from anything likely to compromise the IND approval.
It could be a different matter if we get to March and the FDA is still withholding. At that point the Company might choose to strategically release 3-month data from the Canadian trial for a sample of 6 to assuage safety concerns and hopefuly to include that magic ‘no clinical evidence or presence of disease’ kicker.
This would have positive consequences in either of two circumstances:
If it appeared that the FDA were being unreasonably recalcitrant it would put pressure on them to grant approval.
If it appeared that there was no prospect of short-term FDA Approval it could substantially boost both Canadian recruitment and those seeking recruitment from south of the border - in other words it could save the Trial.
A good shot to have in your locker and for me (and IMHO DYOR) why the stock looks very attractive at these levels because by mid-March the 54c warrants will be out of the way the Company will itself know very well where the Trial is going and we will have either FDA approval or I believe this ann of 3-month Canadian data which in the absence of FDA approval the Company will have every right to make.Either of the last two should result in a substantial re-rating.
Patience will of course be required for the longer haul and for now the stock remains a shorter`s paradise but we are much closer to the finish than where we started. GLTA Longs.