Here Are The Key Timeframes For Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV)

Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) ran up at the start of July on news that the company had appointed a new board member. Subsequent to the announcement, the share price ran to around $2.50 a share from preannouncement pricing of $1.60, but the run did not last long. By market close on Friday, Kitov was back down in and around the $1.75 mark and currently goes for $1.95 ahead of the market open on Tuesday. KTOV Daily ChartThis is a bit of a steep run on the back of what amounts to nothing more than an extra title for someone that already works for the company (the new board member is Gil Ben-Menachem, who has served as the company’s Vice President of Business Development since January 2016) but there is an underlying factor in play here and we think that this has markets eager to pull the trigger on any positive news.If this the case, and when the actual news does hit press, it could really get this company moving ahead of a secondary catalyst (secondary in terms of timeframe, but not in terms of importance), which we will get to in a minute.Here is what we are looking at.The company has a new drug application (NDA) that is, in essence, on hold right now with the FDA in the US. It is rooted in a program called KIT-302, which Kitov is trying to get approved in a target indication of the simultaneous treatment of pain caused by osteoarthritis and hypertension. The application was subject to a fee waiver back in April, based on sections 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, which is granted to a small business for its first human drug application submitted to the FDA for review. This saved the company a little over $2 million at the time and went pretty much unnoticed by markets but, for us, was a decent development.Anyway, that's not overly important from a forward perspective.What is important is that the NDA is being submitted in batches electronically by way of a third party submission platform and, as per management's latest announcement (June 26) is set to complete (as in, the submission will finalize) during the third quarter of this year. Once the submission is finalized and accepted by the FDA (which, with any luck, should also come during the third quarter this year) we will get a PDUFA date for the drug in question. With a PDUFA date in place, markets can get some idea of when this drug will be hitting the shelves.In development stage biotechnology, where capital burn is incredibly important to the near to medium term risk side of the equation, solid time frames (and especially as relates to time-to-revenue-generation) are key to forming a bias. With such a timeframe in place (as outlined by the PDUFA) we think this company will start to attract a large base of speculative volume and – in turn – will start to appreciate in value as KIT-302 advances towards FDA decision day.The submission in question is supported by some strong phase III data as relates to efficacy and safety in the target indication (the above-mentioned pain caused by osteoarthritis and hypertension) meaning that the drug has a fairly good chance of picking up approval on the back of its current application. This is development stage biotechnology, of course, so nothing is guaranteed, but in our opinion, the chances of a regulatory green light look good.Cash is relatively weak right now, so we might see a raise near term (and almost certainly ahead of any commercialization effort) so anyone looking to pick up an early stage holding in anticipation of a regulatory green light needs to keep in mind that they are opening themselves up to some degree of dilution over the coming 12 months.It's not a prohibitive risk, but it's an important consideration.We will be updating our subscribers as soon as we know more. For the latest updates on KTOV, sign up below!Image courtesy of Ian D Keating via FlickrDisclosure: We have no position in KTOV and have not been compensated for this article.