Pharis Mohideen: Sure. So we spent quite a bit of time quite talking to our different sites. And the take-home message we’re getting from them is that, lower had been approved a long time and it has been used off-label with OIT in certain situations. And there hasn’t been huge, huge off-label use for Peanut Allergy, as a standalone indication or even multiple food allergies. And the reason you know for our one to seven year olds the way we’ve been told is, especially in the toddlers one to three, none of the investigators we spoke to would use it as sort of monotherapy for Multiple Food Allergies or Single Food Allergies, because it’s a toddler population. It’s unknown what it would do for a immune system that is still evolving very immature.
And of course, it’s an injectable. In the older patients’ maybe six or seven, what we’ve heard was there could be extreme, extreme cases of patients that are ultra-ultra sensitive. So the anecdote that was told to me was practitioner has a patient who could go to Chuck E. Cheese: and especially so allergic to mount that any of the residual Pizza Cheese Greece that’s on there. And if they have touch them after their eyes they would go into an anaphylactic reaction. And this is just almost straight verbatim what this investigator told me and for a case like that where it’s well documented, that the sensitivity is just extreme and they’ve tried to avoid and done everything they can. That patient might be a candidate for Omalizumab. But again, it’s a pretty extreme case.
And they don’t tend to overlap with our patients very much at all. I don’t know if that helps Jonathan, but that’s just what we’ve gathered as anecdotes talking to as many of the investigators as we can to get an understanding of how the product may be used?
Jon Wolleben: No it’s consistent with what we’re hearing as well.
Pharis Mohideen: Yeah.
Jon Wolleben: So good to hear and thank you for the feedback and color guys.
Daniel Tassé: Sure. The formal market research also besides data with KOL shows. Yeah. It could be used in older kids and adolescents or young adults or multi-allergic at times in their life where you want to make sure that their behavior or whatever they’re experiencing is covered. It’s not the population that we wish to help with our product.
Operator: [Operator Instructions]
Pharis Mohideen: Next question operator.
Operator: [Operator Instructions ]Our next question comes from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.
Sushila Hernandez: Yes. Thank you for taking my question. Could you just walk us through the steps ahead to get to the BLA filing for the Toddlers? And the second question does your cash runway until the end of Phase 4 includes the start of both safety studies? Thank you.
Daniel Tassé: Good question. So the answer is the same for your question is yes, our forecasts have always been as you know, rather smart and conservative. So this assumes the not only the initiation of those two studies, a continuation of the test, a lot of work we do and also when it comes to regulatory dossiers, CSA, CMC, and building up inventory also. So, there’s a lot of our expenses this year are going to that. As far as next steps for toddler dossier, sign-off from the FDA on the protocol and then initiation of the trial. As Pharis said we’ve been in dialogue with many of the investigator sites. We can turn that around pretty quickly. What we don’t know is how quickly this study will enroll. We know there’s a lot of enthusiasm for that study.
We know that food challenges, especially, one that entry in toddlers is easier to do — much easier to do than food challenges in older children. So, we’re confident this study will enroll at a good pace. And but we have no analogs here and for that reason, we’re going to leave that as an open question until we have more data to guide more precisely to study completion BLA filing. We expect also that once we have the clinical data to move to filing a BLA, we’ll move rather quickly. The CMC work will be done by then and it’s not a complex dose here by the way right here. So, it’s pretty straightforward. It comes to the clinical data that we have to fully analyze. Answering your questions, Sushila?
Sushila Hernandez: Yes. Thank you.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.
