RE: RE: Deranged31 Oct 2018 18:43
The additional information required for the expanded Final Trial Management documentation, including the Investigational Brochure, the Investigational Medicinal Product Dossier and Clinical Trial Application for the new trial, are now being completed so that all remaining permissions and approvals are obtained for this trial to commence in """Q1 2014."""
""" The expanded trial is anticipated to yield early results within 8 weeks of commencement."""""
these waffle RNS .. have been on going for years ..
remember YODA and his Fast track Speedy Trials .. every other word he posted was accelerated ...
2015 RNS
With this result, the trial will advance to the next elevation of dose, where further safety and tolerability testing will be undertaken and early stage efficacy will continue to be investigated as the trial progresses. The trial is directed towards providing information on the maximum applicable dose level possible.
2016 end of year
 Phase l/ll Clinical Trial of VAL201 has confirmed that compound is well tolerated up to a putative therapeutic dose and has shown a high degree of safety, with no significant adverse events being reported
Expansion of VAL201 trial into a multi-centre study ???? what happened to that ??
putative
/ˈpjuːtətɪv/Submit
adjective
generally considered or reputed to be.
that didn't work did it ....
2017
yet another dose increase in January ....
Dr Satu Vainikka, CEO of ValiRx, commented: "VAL201 has demonstrated disease stabilisation, with a lower dose than was predicted by our preclinical evaluations. We anticipate that by increasing the dosage we will show a high level of efficacy without compromising the safety and tolerability shown to date to meet the needs of those patients currently under-served by current therapies. ValiRx is entering a very exciting phase, which should result in the crystallisation of substantial value".
By Dec 2017 yet another dose increase ....
·     To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression;Â