RE: Response11 Apr 2024 18:58
I mentioned earlier the there were 2 or 3 particular points in the response which caught my attention.first it was good to see the identity of the manufacturer.second,the figures given re manufacturing capability seem to be of a different order from what we have been told in the past.i sense you feel likewise and are somewhat sceptical of this,a sensible approach bearing in mind how often Regent 's statements have had only a passing acquaintance with accuracy.
the main points however, were their statement about no clinical holds and the reference to royalty financing. does the reference to "no clinical holds"mean that they could in principle (certainly not in practice proceed with a trial ,but without the benefit of a formal SPA?.my understanding,which may well be inaccurate, is that an SPA is not essential for a trial to take place,but the risk is much greater as there would have been no formal agreement with the fda on the criteria and format etc of such trial. having a formal spa in place is, equally, no guarantee of the trial drug being approved, even if the results meet the endpoints specified in the protocol, as the fda will still want to assess the trial results on the basis of their normal criteria. so,having no clinical holds does not mean we have any substantive form of go-ahead, but it does perhaps indicate that the discussions so far with the FDA have achieved some degree of tangible progress. just my musings of course. tbc