GDR - Update16 Jul 2020 17:23
So i've been doing some digging and speaking to someone who's also invested in GDR for his thoughts. This is the current state of play that i believe to be an accurate assessment of where we are.
I've been told post CE, GDR will have applied for regulatory approvals at the earliest point. I think at a push we could level the accusation it was 2 weeks late based on where we are at the moment but given there was no CE for the software tool, this delay might be justified if they wanted to go to market with the software tool as well as the test as a unit.
LP alluded to this in his email comms with Walbrook. For ICMR there are lots of hoops we need to jump through before the tests go to lab. Import licences etc is just part of it. The test is now in the lab as we know, FM has confirmed this. Divoc are our partners in India and they will drive this and not GDR. Why the delay, well they dont just approve any ol' test in India, we know that from independently digging on here (kudos Samolly for the sums). the country is also under extreme pressure with their own Covid pandemic. Think of it like trying to get the attention of the PHE at our peak, except they have 1.2bn people there and things are a lot worse than we had. You ever tried going through an Indian airport, if yes you will know what i mean.
I've spoken to an early NCYT investor and i've been told that in the early days FDA used to take a day for approval. However at the moment its somewhere around 2 months. I wrote around 45 days a day or two ago and that seems to be correct (working days). Its been a month already, so max tentative timescales indicate its another 3-4 weeks away, maybe sooner. FDA have been chased up based on my comms with the PR office but FDA wont disclose dates to GDR.
During approval stages, the labs dont just take your data, test and come back with a yes or no. They evaluate, they ask questions, they sometimes need more information. They sometimes want more tests. Given the state of play in India, the ICMR testing program has around 14 labs involved and there is data travelling back and forth within potentially all 14 centres involved in the approval process. GDR have stated on the record they are confident of getting this approval. Our validation has started and is well underway there.
I can say with a degree of certainty that the 1m sales order is for India. That's the furthest we are in the approvals so likelihood is those are Indian sales. 1m sales is around 125k tests @ £8 a test or more based on lower cost for sales. Once word spreads more tests will come.
NHS I dont think we are in there in the short term, its something GDR have submitted into (source Crowdcity), NHS / PHE are fully geared up at the moment, if the incumbents are removed for some reason that might work for us. The company has never publicly said they are trying to sell to the NHS, the last RNS also doesnt say that.
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