" End of P2 meeting in 1Q13
- Full data presentation in March
- Corporate partnership
- Start of Phase 3 targeted in 4Q13"
Of those four goals, I think the only one that would add significant value at this point would be the partnership because it would signify that at least one
company thought Brem was worth gambling on.
We already know the Phase 2 results were probably good enough to have an End of Phase 2 meeting and probably to progress to Phase 3. So that should basically be in the stock price.
My opinion therefore, is to be conservative, I wouldn't assign more than a $115 million market cap for that set of events.
If there are 107.157 million shares, that would be a stock price of about $1.07 maximum.
Then again, I thought good Phase 2 results would get the stock price up to about $1.
So I've been overly optimistic.
I don't think it's given that the EOp2 meeting will go well. We were at this same point 5 years ago. Everything looked ready for a p3 study, but then the FDA told PTN about their BP concerns which caused the stock to collapse. We know there is an average increase of 2mmHg in the p2b study. We don't know the outlier data yet. If some outliers have massive spikes in BP, and the company has no way to screen for it in the clinic, then the drug may be in trouble. The other factor that helps brem in this situation is that there are no existing treatments for the indication, so the BP issue will be evaluated differently (and IMO, more leniently).
I'm assuming from the insider buys, that the BP issues may have been overcome.
I think the next catalyst will be a positive EOP2 meeting with the FDA. Although the efficacy data was reportedly good (I haven't seen the actual data), bremelanotide's progression to phase 3 is not guaranteed. The hypertension issue hasn't completely disappeared until the outlier data is presented. Also the company could potentially complete a couple of phase 3 trials on its own with additional funding. Such funding, let's say $50 million, might have an overall economic effect less than partnering with a large pharma in exchange for mere royalty payments on sales.
I don't see a meaningful P3 sans partner - so I agree there. It is also important to remember that FDA typically doesnt stop a company from running a phase 3 at the company's risk (unless there are safety or risk benefit concerns) if the company doesn't adhere to their advice (eg Hemispherix and Chelsea). So the external validation of a real partner is key here.
Phil, let's say Brem gets through PH III and is approved by the FDA. Is the condition that it's treating going to be covered by health insurance? Just what is the market potential for the female Cialis?