Hi Growler & All,
Just catching up on all of this, thank you very much to you & everyone for all this information.
My initial thought was contingencies being put in place now to complete the Ph3 FSGS in the event that the FDA does not accept the Interim data for Accelerated approval. It happened to Travere on Sparsentan trial for FSGS, but IgAN indication was granted on interim data. If anyone’s crystal ball can channel FDA decisions, please let me know lol.
In the current climate, & I have been holding here a very long time, it’s probably wise to do this now, rather than being strung up by the balls so to speak once we reach the interim data point.
I get your points though totally
@BT, why not raise more @20c? $20 million was a big raise for us back then, & being invested in other Biotechs also, which have been slammed, it’s no easy task.
I also agree with your comments regarding ‘Cash is King’ - we want to be in a position to be able to fund completion of the Orphan Status indication AT LEAST for DMX-200.
I also wonder about the new REMAP-CAP ILD (Interstitial Lung Disease) trial that is well into the planning phase for protocol & statistics. There are 2 Novel antifibrotic drugs that will be included on that trial. Not saying DMX-200 will be one of those, but it’s possible. ILD can be an outcome from COVID-19 infection (ie long COVID & other causes). If you Google that on Twitter there are some publicly available Webinars there. Both for Medical & Patients. This is also a clinically unmet need at present.
Unfortunately there were only 6 patients recruited onto the REMAP-CAP trial, so the only real data we have is to compare to patients who were eligible for that arm in severe disease. That would be to do with Protocol & recruitment onto an arm that is a novel drug & other investigational interventions were excluded from, plus trial site choice of interventions. The good news is there was 0/6 safety issues on this arm, in light of the trial being stopped for ACEi/ARB safety concerns in severe disease (moderate disease was inconclusive). An external trial.
I guess we will see all the terms in relation to this CR this morning, and of course am disappointed in our SP as well at present. I will be participating within my means pending the official ANN.
To our lovely
@Malabra, who has been here forever. I hope you are OK & yes Prof Packham running our Ph2s! You are in good hands there my friend. If you go back over old ANNs & Webinar post Ph2 DKD you will see. Take care & I hope you are OK. x
Chat later after VS lifted.
(20min delay)