You have been pumped by CEO and don't know any thing about ABX development nor commercial prospects for new ABXs. You will Lose your money!
1. The in vitro resistance profile of Soli is just only slightly better than commercial macrolides and on par with other ketolides (like Ketek). And as fact, as mentioned numerous times, clinical resistance is not observable in clinic since the PK/PD is the dictating factor (I.e. High concentrations Staying above the MIC). That's why one sees similar global cure rates between ABXs. I guarantee you that a head to head with AZithromycin would give NI global cure rates......jeez if Soli was so great, this would be a no brainier trial to run.
2-9). Non refutable
Arguments for shorting:
1. NI end point; means similar global clinical cure rates; which means similar to many other ABXs; which means no marketing advantage. Cemp can't argue resistance is an issue...
2. No pharma partner at this stage huge red flag about commercial prospects
3. Go at alone means huge sales/commercially expense in a low value market for Soli
4. Me-too class
5. CEO trying to make this a wonder drug with other indications.....really?
6. CEO is car salesman and hypes studies/drugs....."keep fingers crossed"
7. More significant dilution coming based on above expenses
8. Bungled prior offering
9. List goes on and on and on......
Very weak points made in that article. The FDA looks at benefit/risk very holitistically and in totality of all the data. The author claims Remoxy as a ADF is flawed and not technically aligned with FDA guidance in order to #$%$ investors such as yourself. The only thing flawed is his reasoning and conclusions. Remoxy will add to the ADF arsenal and a welcomed drug with several advantages.....assuming manufacturing issues are addressed.
That article is a typical example of not seeing the forest for the trees. Remoxy is indeed needed as ADF option with certain advantages over competition. The reference study drug used in the PK study after chewing could only be done with commercially available drug at the time. This is only one factor and many other factors indicate a very positive benefit/risk profile as an ADF.
No...by all accounts Cemp one of the worst as they come. The benefit/cost is simply won't be justified based on NI label. Cemp would have been bought out a long time ago....simple reason horrible commercial potential!
Over 1billion valuation with a non-inferiority label and other cheap ABXs working as well. Completely ridiculous. The retail investors continued to be suckered in. Sales will significantly underperform and expenses wiill rise dramatically.....seen this story before! Big pharma won't touch this....
Longs chance to get out of your nightmare of an investment. At current value, Trust there will be more down days than up. Eventually will go to single digits. The latest PRs are sooo pumping....