I am poster 358 and am not poster 354. Dont understand what you mean really? Who is Ms. Moore? I am just a seasonal investor who just did DD on DOVA after its slump in Dec.
Basically, his analysis adds nothing new:
Everyone knows sales would struggle with CLD due to the planning time before procedure (this is new and is not SOC so docs dont actively plan ahead). The only game changer for DOVA in CLD is when it becomes SOC.
Regarding cITP sNDA approval, his conclusion provides nothing new - none could be sure what FDA will decide. And obviously, eltrombopag is the first in class at that time so not only its trial could recruit more pats but also would require more data to prove TPO-RA's safety and efficiency. Same works in CLD for ava when it is 1st in class, DOVA could recruit more pats for their trial and would need thousands for its application. To me, any PDUFA is binary. However, it is obvious that FDA would base on two important criterias: Safety and Efficiency. Here, Safety profile is OK (with data from thousands of pats) only Efficiency is slightly questionable (as data on cITP is a bit limited due to enrollment difficulty though its efficiency in raising platelet count is proved in CLD and TPO-RA class is proved efficient with cITP pats for 10 years now).
Competition: it will again depend on its label when being approved: whether it has black box warning or not so this could not be discussed like in that article. If it doesnt have black box warning like Promacta, it is a plus for sure. And the convenience of administration is also a bonus (sometimes it would effect a lot on purchase decision - it is really troublesome to always have to remember to take med in empty stomach - my own experience). Just think of CLD, platelet tranfusion is convenient (no ned to plan ahead if the center have facility available) vs tablet administration (planning ahead). Just a slight convenience makes such difference. And you are talking about competition in a $billion market for a company with current valuation of less than $150mil? Even a slight bite in that cake would help a lot to break even. Besides Nplate, Promacta, Tavalisse, all others are still in phase 2 and everyone know how long and how likely success is to come from phase 2 to approval.
IP status: Drug normally has 20 years IP but all the trial should take roughly 10 years+ to approval. So you should look at around less than 10 years for the original IP. As far as I know from talking to John Woolford of Westwicke Partners (DOVA customer relations), they are filing for patent extension and are waiting for result, expected to come back within the next 3-6 mos.
Cash position is decent (compared to which company?): Most startups are not cash rich, mostly enough to sustain operation for 18 months so the article must be confused with big pharms. The thing I like here in DOVA is they have good cash from previous offering at quite high price with small long term debt (that has been reorganised early). This comes with a reasonable cash burn (compared to others with huge cash burn for example SGYP that the author pumped last year) and a good profit margin (allow them to adjust price strategy if needed)
Funds are leaving: the authors donot do a proper DD. Yes, some left and some opened new positions. In total, a deduction of around 615K shares in a company with 28.24 million shares in Dec 2018. This is contributed mostly by Nexthera Capital (a $400mil hedge fund) closing position. None knows why though there is possibility for tax loss before eoy or simply they sell to repurchase later? However, the sell is done now and if the hedge funds start to come back, it will move SP much better than none sell and none buy (terrible liquidity) and create more attention from retail investors (the followers)
For future, CIT is a big market and investible or not would very much depend on how likely the success of their phase 3 is.
Dont know if I have covered / "disputed" all the points talked in that article or not and obviously I might be wrong. But one thing for sure is the ITP and CIT indication has not been priced in the current share price (all eye still on the smallest indication: CLD). As a seasonal investor, the risk - reward ratio is quite favorable in this one.
