Hayward Pharma/DMF/Sales Cycle 5/3/18: New Pharma customer announcement this month?
"Okay. First of all, thank you for your question and I just want to use it as an opportunity to ensure that we make clear the process of FDA approval. So now that we have finaled our DMF and once it goes through administrative review, it is formally accepted for storage-only by FDA and it does not undergo review until such time as the FDA receives a second request, which we enable from a pharmaceutic customer who references our DMF in the application for their drug. So that would be when we obtain a new customer and that begins the FDA’s process of reviewing the secret content of our DMF currently in storage at FDA and hopefully getting past the administrative review. That could be months from now and we don’t know – we can’t vouch for how long the FDA’s process may take. And so the path to revenue is really not in our hands and we will just have to see how long that takes them bring in as many customers as we can in the interim.
Sure. In some ways, the management at FDA of DMFs can be something of a model like the Russian dolls. That is our DMF is referenced by Colorcon in the assembly of their coding and the DMF that describes their coding. So, it’s a DMF within a DMF. Now together, we would sell that DNA-tagged coding to a pharmaceutic customer to a manufacturer of a drug. And either it’s a new drug that might be involved in the filing of an IND or an ANDA or it could be an existing legacy drug where FDA is informed during an annual report for that drug. So, it’s only then that our data will be reviewed. Now, we have not been spending much money in the advertisement and marketing of our platform to-date, we wanted to get through our DMF filing. But what we have been doing is talking to the industry and the response in the industry has been strong.
Sure. I also want to highlight another quality and benefit of our working with Colorcon. It’s not just their substantial sales team and marketing, but it is their substantial regulatory and compliance team with experience globally. So of course, FDA is one issue, but Europe is a very attractive market as well as the rest of the world and a truly global pharmaceutic company that sells additives like Colorcon, needs to have customers that are truly global as well. So it means they need to be familiar with all the world’s compliance issues and we get that. We are very lucky to get that from Colorcon. Now in terms of our go-to-market at the moment, it’s been quite simple. We are making four-legged sales calls on the big pharmaceutical companies across the industry. And with those sales calls, we have seen a great response and we are developing a pipeline as we speak and I am pleased with the quality and number of potential leads in that pipeline.
Yes. That would not be a complication, Craig. So what happens is with the DMF on file after administrative review at FDA when a company wants to refer to our DMF, we provide a letter of access to FDA. That does not give our DMF to the company. It allows FDA to review our DMF for the sake of safety and compliance and as used within the drug company’s drug, does it in anyway impact safety? Now, our position of course – our belief is that there is no way our DNA would impact safety, but it’s not for us to judge, that’s for FDA to judge and that is done drug company by drug company by drug company. So, it really doesn’t matter if we were successful and we had a team of pharmaceutic companies approaching FDA at the same time. It would be – have no impact on us at all. We just have to be ready to supply in the event they are approved. All of that work is within under the aegis of FDA, not us."
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